NDC Code(s) : 0121-0867-20, 0121-0890-20
Packager : PAI Holdings, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0867
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD)
(VANCOMYCIN - UNII:6Q205EH1VU) 		VANCOMYCIN125 mg
Inactive Ingredients
Ingredient Name Strength
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)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0121-0867-202 in 1 CARTON 25/07/2019
110 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210729 07/25/2019
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0890
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD)
(VANCOMYCIN - UNII:6Q205EH1VU) 		VANCOMYCIN250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0121-0890-202 in 1 CARTON 25/07/2019
110 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210729 07/25/2019

LABELER - PAI Holdings, LLC(044940096)

PRINCIPAL DISPLAY PANEL

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Vancomycin Hydrochloride Capsules USP, Equiv. to 250 mg vancomycin NDC 0121-0890-20, Rx Only 20 Capsules

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