NDC Code 62175-458-32 - Buprenorphine Hydrochloride

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

Buprenorphine and NaloxoneBuprenorphine and Naloxone TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE(UNII: 40D3SCR4GZ) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	2 mg
NALOXONE(UNII: 36B82AMQ7N) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM CITRATE(UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62175-452-32	30 in 1 BOTTLE Type 0: Not a Combination Product	19/09/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205022	09/19/2016

Buprenorphine and NaloxoneBuprenorphine and Naloxone TABLET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE(UNII: 40D3SCR4GZ) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	8 mg
NALOXONE(UNII: 36B82AMQ7N) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	2 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM CITRATE(UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62175-458-32	30 in 1 BOTTLE Type 0: Not a Combination Product	19/09/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205022	09/19/2016

LABELER - Lannett Company, Inc.(006422406)

Establishment
Name	Address	ID/FEI	Business Operations
Lannett Company, Inc.		006422406	analysis(62175-452, 62175-458), label(62175-452, 62175-458), manufacture(62175-452, 62175-458), pack(62175-452, 62175-458)

NDC 62175-458-32
API & Excipient Details