NDC Code(s) : 68382-943-01, 68382-944-01, 68382-945-01
Packager : Zydus Pharmaceuticals (USA) Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine SulfateDextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-943
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE5 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
OLEIC ACID(UNII: 2UMI9U37CP)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color BROWN, BROWN Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code N;943
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-943-01100 in 1 BOTTLE Type 0: Not a Combination Product28/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017
Dextroamphetamine SulfateDextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-944
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE10 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
OLEIC ACID(UNII: 2UMI9U37CP)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE, BROWN Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code N;944
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-944-01100 in 1 BOTTLE Type 0: Not a Combination Product28/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017
Dextroamphetamine SulfateDextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-945
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE15 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
OLEIC ACID(UNII: 2UMI9U37CP)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE, BROWN Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code N;945
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-945-01100 in 1 BOTTLE Type 0: Not a Combination Product28/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017

LABELER - Zydus Pharmaceuticals (USA) Inc. (156861945)

REGISTRANT - Nesher Pharmaceuticals (USA) LLC (969028351)

Establishment
Name Address ID/FEI Business Operations
Nesher Pharmaceuticals (USA) LLC 969028351 ANALYSIS(68382-943, 68382-944, 68382-945), MANUFACTURE(68382-943, 68382-944, 68382-945)

PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-943-01    CII

Dextroamphetamine Sulfate Extended-Release Capsules

5 mg

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

Bottle Label 5 mgBottle Label 5 mg

PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-944-01    CII

Dextroamphetamine Sulfate Extended-Release Capsules

10 mg*

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

10 mg Bottle Label10 mg Bottle Label

PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-945-01    CII

Dextroamphetamine Sulfate Extended-Release Capsules

15 mg*

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

15 mg Bottle Label15 mg Bottle Label