Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-548-01
5 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-548-01pl-300x88.jpg
(click image for full-size original)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-549-01
10 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-549-01pl-300x100.jpg
(click image for full-size original)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-550-01
15 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-550-01pl-300x86.jpg
(click image for full-size original)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-551-01
20 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-551-01pl-300x94.jpg
(click image for full-size original)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-552-01
25 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-552-01pl-300x107.jpg
(click image for full-size original)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

NDC 51407-553-01
30 mg

CII 100 Capsules

Rx only

//medlibrary.org/lib/images-rx/dextroamphetamine-saccharate-amphetamine-aspartate-monohydrate-dextroamphetamine-sulfate-and-amphetamine-sulfate-17/51407-553-01pl-300x117.jpg
(click image for full-size original)
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-548(NDC:0527-5510)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 1.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
SUCROSE
TALC
TRIETHYL CITRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color white, green (lime green) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 5mg;ELI;510
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-548-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-549(NDC:0527-5511)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 2.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
SUCROSE
TALC
TRIETHYL CITRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 10mg;ELI;511
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-549-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-550(NDC:0527-5512)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.75 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.75 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.75 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
SUCROSE
TALC
TRIETHYL CITRATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color white, green Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 15mg;ELI;512
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-550-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-551(NDC:0527-5513)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
SUCROSE
TALC
TRIETHYL CITRATE
FD&C RED NO. 3
FD&C RED NO. 40
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color white, pink (Light Pink) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 20mg;ELI;513
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-551-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-552(NDC:0527-5514)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 6.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 6.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SUCROSE
TALC
TRIETHYL CITRATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 25mg;ELI;514
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-552-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-553(NDC:0527-5515)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 7.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 7.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
HYPROMELLOSE 2910 (50 MPA.S)
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
SUCROSE
TALC
TRIETHYL CITRATE
D&C RED NO. 28
FD&C RED NO. 40
FD&C YELLOW NO. 6
PROPYLENE GLYCOL
SHELLAC
FD&C BLUE NO. 1–ALUMINUM LAKE
Product Characteristics
Color white, pink (Dark Pink) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 30mg;ELI;515
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-553-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212037 12/11/2019
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-548), repack (51407-548), relabel (51407-549), repack (51407-549), relabel (51407-550), repack (51407-550), relabel (51407-551), repack (51407-551), relabel (51407-552), repack (51407-552), relabel (51407-553), repack (51407-553)

Revised: 12/2020 Golden State Medical Supply, Inc.

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