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 CII
5 mg
NDC 43975-277-10
100 Capsules
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only

Label-5mg
(click image for full-size original)

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 CII
10 mg
NDC 43975-278-10
100 Capsules
PHARMACIST:
Dispense the accompanying Medication Guide to each patient.
Rx only

Label-10mg
(click image for full-size original)

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 CII
15 mg
NDC 43975-279-10
100 Capsules
PHARMACIST:
Dispense the accompanying Medication Guide to each patient.
Rx only

Label-15mg
(click image for full-size original)

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 CII
20 mg
NDC 43975-280-10
100 Capsules
PHARMACIST:
Dispense the accompanying Medication Guide to each patient.
Rx only

Label-20mg
(click image for full-size original)

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 CII
25 mg
NDC 43975-281-10
100 Capsules
PHARMACIST:
Dispense the accompanying Medication Guide to each patient.
Rx only

Label-25mg
(click image for full-size original)

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 CII
30 mg
NDC 43975-282-10
100 Capsules
PHARMACIST:
Dispense the accompanying Medication Guide to each patient.
Rx only

Label-30mg
(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:43975-277
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.25 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (clear body) , GREEN (green opaque cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code AMG;277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-277-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
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:43975-278
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (green opaque body and cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code AMG;278
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-278-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
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:43975-279
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.75 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.75 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (white opaque body) , GREEN (green opaque cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AMG;279
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-279-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
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:43975-280
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (pink opaque body and cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AMG;280
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-280-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
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:43975-282
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 7.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 7.5 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (clear body) , PINK (pink opaque cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AMG;282
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-282-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
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:43975-281
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 6.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 6.25 mg
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
GLYCERYL MONOSTEARATE
POLYSORBATE 80
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIACETIN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
GELATIN, UNSPECIFIED
FD&C RED NO. 40
SHELLAC
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (white opaque body) , PINK (pink opaque cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AMG;281
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43975-281-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205401 03/16/2020
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 03/2022 ANI Pharmaceuticals, Inc.

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