NDC Code 43602-266-05 - Hydromorphone Hydrochloride

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	8 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-266-30	30 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020
2	NDC:43602-266-05	500 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	12 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-267-30	30 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020
2	NDC:43602-267-05	500 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	16 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-268-30	30 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020
2	NDC:43602-268-05	500 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROMORPHONE HYDROCHLORIDE(UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)	HYDROMORPHONE HYDROCHLORIDE	32 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43602-269-30	30 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020
2	NDC:43602-269-05	500 in 1 BOTTLE Type 0: Not a Combination Product	24/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

NDC 43602-266-05
API & Excipient Details

Hydromorphone Hydrochloride marketed by Ascent Pharmaceuticals, Inc. under NDC Code 43602-266-05

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.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43602-266-05 API & Excipient Details

Hydromorphone Hydrochloride marketed by Ascent Pharmaceuticals, Inc. under NDC Code 43602-266-05

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

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43602-266-05
API & Excipient Details

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.