NDC Code(s) : 76333-264-26, 76333-264-01, 76333-264-17, 76333-265-26, 76333-265-01, 76333-265-17
Packager : Orient Pharma Co.,Ltd Yunlin Plant

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:76333-264
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76333-264-012 in 1 CARTON 25/07/2019
1NDC:76333-264-2610 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:76333-264-1750 in 1 BOTTLE Type 0: Not a Combination Product25/07/2019
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:76333-265
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
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76333-265-012 in 1 CARTON 25/07/2019
1NDC:76333-265-2610 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:76333-265-1750 in 1 BOTTLE Type 0: Not a Combination Product25/07/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210729 07/25/2019

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

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

Establishment
Name Address ID/FEI Business Operations
Orient Pharma Co.,Ltd 658849810 manufacture(76333-264, 76333-265)

PRINCIPAL DISPLAY PANEL

Vancomycin Hydrochloride Capsules USP, Equiv. to 125 mg vancomycin NDC 76333-264-26 Rx Only 20 Capsules

5a12419-8079-48fc-9b85-2fae31b12ee2 5a12419-8079-48fc-9b85-2fae31b12ee2

Vancomycin Hydrochloride Capsules USP, Equiv. to 250 mg vancomycin NDC 76333-265-26 Rx Only 20 Capsules

5a12419-8079-48fc-9b85-2fae31b12ee25a12419-8079-48fc-9b85-2fae31b12ee2

Vancomycin Hydrochloride Capsules USP, Equiv. to 125 mg vancomycin NDC 76333-264-17 Rx Only 50 Capsules

5a12419-8079-48fc-9b85-2fae31b12ee2

Vancomycin Hydrochloride Capsules USP, Equiv. to 250 mg vancomycin NDC 76333-265-17 Rx Only 50 Capsules

5a12419-8079-48fc-9b85-2fae31b12ee2