NDC Code 76333-265-26 - Vancomycin Hydrochloride

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE CAPSULE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)	VANCOMYCIN	125 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SHELLAC(UNII: 46N107B71O)
GLYCERYL MONOOLEATE(UNII: C4YAD5F5G6)

Product Characteristics
Color	blue (Blue Cap), yellow (Yellow Body)	Score	no score
Shape	CAPSULE (Capsule)	Size	18 mm
Flavor		Imprint Code	OP;64
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76333-264-01	2 in 1 CARTON	25/07/2019
1	NDC:76333-264-26	10 in 1 BLISTER PACK Type 0: Not a Combination Product
2	NDC:76333-264-17	50 in 1 BOTTLE Type 0: Not a Combination Product	25/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210729	07/25/2019

VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE CAPSULE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)	VANCOMYCIN	250 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SHELLAC(UNII: 46N107B71O)
GLYCERYL MONOOLEATE(UNII: C4YAD5F5G6)

Product Characteristics
Color	blue (Blue Cap), yellow (Dark-Yellow Body)	Score	no score
Shape	CAPSULE (Capsule)	Size	22 mm
Flavor		Imprint Code	OP;65
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76333-265-01	2 in 1 CARTON	25/07/2019
1	NDC:76333-265-26	10 in 1 BLISTER PACK Type 0: Not a Combination Product
2	NDC:76333-265-17	50 in 1 BOTTLE Type 0: Not a Combination Product	25/07/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210729	07/25/2019

LABELER - Orient Pharma Co.,Ltd Yunlin Plant(658849810)

REGISTRANT - Orient Pharma Co.,Ltd Yunlin Plant(658849810)

NDC 76333-265-26
API & Excipient Details