DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (Page 9 of 9)

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5mg-500s
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10mg-30s
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10mg-500s
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15mg-30s
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15mg-500s
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20mg-30s
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20mg-500s
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25mg-30s
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25mg-500s
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30mg-30s
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30mg-500s
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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:43602-316
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
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
SODIUM LAURYL SULFATE
SUCROSE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 5mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-316-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-316-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
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:43602-317
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
SUCROSE
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
SODIUM LAURYL SULFATE
D&C RED NO. 28
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 10mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-317-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-317-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
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:43602-318
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
SUCROSE
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C BLUE NO. 1
D&C RED NO. 28
GELATIN
SODIUM LAURYL SULFATE
Product Characteristics
Color white, blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 15mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-318-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-318-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
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:43602-319
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
SUCROSE
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C RED NO. 3
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
GELATIN
SODIUM LAURYL SULFATE
FD&C RED NO. 40
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 20mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-319-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-319-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
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:43602-320
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
SUCROSE
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
SODIUM LAURYL SULFATE
Product Characteristics
Color white, orange Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 25mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-320-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-320-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
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:43602-321
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
SUCROSE
HYPROMELLOSES
TALC
TRIETHYL CITRATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:2)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
POLYSORBATE 80
FERRIC OXIDE RED
SHELLAC
DEHYDRATED ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
SODIUM LAURYL SULFATE
GELATIN
Product Characteristics
Color yellow, white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 30mg;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-321-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-321-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214959 09/29/2021
Labeler — Ascent Pharmaceuticals, Inc (080938961)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals, Inc 080938961 analysis (43602-316), analysis (43602-317), analysis (43602-318), analysis (43602-319), analysis (43602-320), analysis (43602-321), manufacture (43602-316), manufacture (43602-317), manufacture (43602-318), manufacture (43602-319), manufacture (43602-320), manufacture (43602-321), PACK (43602-316), PACK (43602-317), PACK (43602-318), PACK (43602-319), PACK (43602-320), PACK (43602-321)

Revised: 09/2021 Ascent Pharmaceuticals, Inc

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