NDC Code(s) : 66993-210-19, 66993-211-19
Packager : Prasco Laboratories

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:66993-210
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. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE, BROWN Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 3125;VANCOCIN;HCL;125;MG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-210-192 in 1 CARTON
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
NDA AUTHORIZED GENERIC NDA050606 04/10/2012
Vancomycin Hydrochloridevancomycin hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-211
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. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BLUE, PURPLE (lavender) Score no score
Shape CAPSULE (CAPSULE) Size 22 mm
Flavor Imprint Code 3126;VANCOCIN;HCL;250;MG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-211-192 in 1 CARTON
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
NDA AUTHORIZED GENERIC NDA050606 04/10/2012

PRINCIPAL DISPLAY PANEL

Vancomycin Hydrochloride Capsules USP, Equiv. to 125 mg vancomycin

NDC 66993-210-19

Rx Only

20 Capsules

Vancomycin 125mg Carton

PRINCIPAL DISPLAY PANEL

Vancomycin Hydrochloride Capsules USP Equiv. to 250 mg vancomycin

NDC 66993-211-19

Rx Only

20 Capsules

 Vancomycin 250mg Carton