NDC Code(s) : 63187-787-30, 63187-787-60, 63187-787-90, 63187-787-72, 63187-787-78
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OmeprazoleOmeprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-787(NDC:68462-231)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CETYL ALCOHOL(UNII: 936JST6JCN)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: 94255I6E2T)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
MANNITOL(UNII: 3OWL53L36A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
Product Characteristics
Color PURPLE (Purple blue body and purple blue cap) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G;G231
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-787-3030 in 1 BOTTLE Type 0: Not a Combination Product12/01/2016
2NDC:63187-787-6060 in 1 BOTTLE Type 0: Not a Combination Product12/01/2016
3NDC:63187-787-9090 in 1 BOTTLE Type 0: Not a Combination Product12/01/2016
4NDC:63187-787-72120 in 1 BOTTLE Type 0: Not a Combination Product12/01/2016
5NDC:63187-787-78180 in 1 BOTTLE Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091672 10/31/2014

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(63187-787), RELABEL(63187-787)

PRINCIPAL DISPLAY PANEL

63187-787-30