Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 5 mg Capsule Bottle Label

NDC 0781-2329-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

5 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 5 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

NDC 0781-2335-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

10 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg Capsule Bottle Label

NDC 0781-2343-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

15 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 15 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

NDC 0781-2352-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

20 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 20 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Capsule Bottle Label

NDC 0781-2368-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

25 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 25 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Bottle Label

NDC 0781-2371-01

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

(Mixed Salts of A Single-Entity
Amphetamine Product)
CII

Extended-Release Capsules

30 mg

Rx Only

Pharmacist: Medication Guide to bedispensed to patients.

100 Capsules

SANDOZ

PRINCIPAL DISPLAY PANEL -- 30 mg Capsule Bottle Label
(click image for full-size original)
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2329
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
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code M;Amphet;Salts;5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2329-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2335
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
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code M;Amphet;Salts;10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2335-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2343
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
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.75 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.75 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FD&C BLUE NO. 2
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color BLUE, WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code M;Amphet;Salts;15;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2343-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2352
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code M;Amphet;Salts;20;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2352-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2368
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
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 6.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color ORANGE, WHITE Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code M;Amphet;Salts;25;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2368-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, 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:0781-2371
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
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 7.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
SUCROSE
TALC
TRIETHYL CITRATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
OPADRY YS-1-17274A BEIGE
Product Characteristics
Color BROWN, ORANGE Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code M;Amphet;Salts;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-2371-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021303 04/02/2009
Labeler — Sandoz Inc (005387188)
Establishment
Name Address ID/FEI Operations
Cambrex Charles City, Inc 782974257 API MANUFACTURE (0781-2329), API MANUFACTURE (0781-2335), API MANUFACTURE (0781-2343), API MANUFACTURE (0781-2352), API MANUFACTURE (0781-2368), API MANUFACTURE (0781-2371)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 ANALYSIS (0781-2329), ANALYSIS (0781-2335), ANALYSIS (0781-2343), ANALYSIS (0781-2352), ANALYSIS (0781-2368), ANALYSIS (0781-2371), LABEL (0781-2329), LABEL (0781-2335), LABEL (0781-2343), LABEL (0781-2352), LABEL (0781-2368), LABEL (0781-2371), MANUFACTURE (0781-2329), MANUFACTURE (0781-2335), MANUFACTURE (0781-2343), MANUFACTURE (0781-2352), MANUFACTURE (0781-2368), MANUFACTURE (0781-2371), PACK (0781-2329), PACK (0781-2335), PACK (0781-2343), PACK (0781-2352), PACK (0781-2368), PACK (0781-2371)
Establishment
Name Address ID/FEI Operations
Unither Manufacturing LLC 079176615 ANALYSIS (0781-2335), ANALYSIS (0781-2343), ANALYSIS (0781-2352), ANALYSIS (0781-2368), ANALYSIS (0781-2371), MANUFACTURE (0781-2335), MANUFACTURE (0781-2343), MANUFACTURE (0781-2352), MANUFACTURE (0781-2368), MANUFACTURE (0781-2371)
Establishment
Name Address ID/FEI Operations
Sharp Packaging Services, LLC 143696495 LABEL (0781-2329), LABEL (0781-2335), LABEL (0781-2343), LABEL (0781-2352), LABEL (0781-2368), LABEL (0781-2371), PACK (0781-2329), PACK (0781-2335), PACK (0781-2343), PACK (0781-2352), PACK (0781-2368), PACK (0781-2371)

Revised: 03/2022 Sandoz Inc

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