NDC Code(s) : 43602-266-30, 43602-266-05, 43602-267-30, 43602-267-05, 43602-268-30, 43602-268-05, 43602-269-30, 43602-269-05
Packager : Ascent Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

hydromorphone hydrochloridehydromorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-266
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW)
(HYDROMORPHONE - UNII:Q812464R06) 		HYDROMORPHONE HYDROCHLORIDE8 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POVIDONE(UNII: FZ989GH94E)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ACETONE(UNII: 1364PS73AF)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color pink (light pink to pink) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 266
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-266-3030 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
2NDC:43602-266-05500 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212133 09/24/2020
hydromorphone hydrochloridehydromorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-267
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW)
(HYDROMORPHONE - UNII:Q812464R06) 		HYDROMORPHONE HYDROCHLORIDE12 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POVIDONE(UNII: FZ989GH94E)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ACETONE(UNII: 1364PS73AF)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color yellow (light yellow to yellow) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 267
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-267-3030 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
2NDC:43602-267-05500 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212133 09/24/2020
hydromorphone hydrochloridehydromorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-268
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW)
(HYDROMORPHONE - UNII:Q812464R06) 		HYDROMORPHONE HYDROCHLORIDE16 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POVIDONE(UNII: FZ989GH94E)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ACETONE(UNII: 1364PS73AF)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color brown (Light beige to beige) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 268
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-268-3030 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
2NDC:43602-268-05500 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212133 09/24/2020
hydromorphone hydrochloridehydromorphone hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-269
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW)
(HYDROMORPHONE - UNII:Q812464R06) 		HYDROMORPHONE HYDROCHLORIDE32 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POVIDONE(UNII: FZ989GH94E)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ACETONE(UNII: 1364PS73AF)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code 269
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43602-269-3030 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
2NDC:43602-269-05500 in 1 BOTTLE Type 0: Not a Combination Product24/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212133 09/24/2020

LABELER - Ascent Pharmaceuticals, Inc.(080938961)

REGISTRANT - Ascent Pharmaceuticals, Inc.(080938961)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis(43602-266, 43602-267, 43602-268, 43602-269), manufacture(43602-266, 43602-267, 43602-268, 43602-269), pack(43602-266, 43602-267, 43602-268, 43602-269)

PRINCIPAL DISPLAY PANEL

8 mg- 30s

8 mg- 30s

8 mg- 30s

8 mg- 30s