NDC 31722-149-05
API & Excipient Details

Gabapentin marketed by Camber Pharmaceuticals, Inc. under NDC Code 31722-149-05

NDC Code(s) : 31722-148-01, 31722-148-05, 31722-148-10, 31722-149-01, 31722-149-05, 31722-150-01, 31722-150-05
Packager : Camber Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GABAPENTINgabapentin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:31722-148
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	100 mg

Ingredient Name	Strength
Inactive Ingredients
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	16 mm
Flavor		Imprint Code	A;469
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31722-148-01	100 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021
2	NDC:31722-148-05	500 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021
3	NDC:31722-148-10	1000 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214956	05/10/2021

GABAPENTINgabapentin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:31722-149
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	300 mg

Ingredient Name	Strength
Inactive Ingredients
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	19 mm
Flavor		Imprint Code	A;470
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31722-149-01	100 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021
2	NDC:31722-149-05	500 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214956	05/10/2021

GABAPENTINgabapentin CAPSULE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:31722-150
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
FD&C RED NO. 40(UNII: WZB9127XOA)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	21 mm
Flavor		Imprint Code	A;471
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31722-150-01	100 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021
2	NDC:31722-150-05	500 in 1 BOTTLE Type 0: Not a Combination Product	05/10/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214956	05/10/2021

LABELER - Camber Pharmaceuticals, Inc.(826774775)

Establishment
Name	Address	ID/FEI	Business Operations
Ascent Pharmaceuticals, Inc.		080938961	analysis(31722-148, 31722-149, 31722-150), manufacture(31722-148, 31722-149, 31722-150), pack(31722-148, 31722-149, 31722-150)

PRINCIPAL DISPLAY PANEL

100 mg

100 mg

100 mg

100 mg

100 mg

100 mg

100 mg