NDC Code(s) : 63187-061-30, 63187-061-60, 63187-061-90, 63187-061-72, 63187-061-78, 63187-070-14, 63187-070-30, 63187-070-60, 63187-070-90, 63187-070-72, 63187-070-78
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:63187-061(NDC:60505-0145)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(Omeprazole - UNII:KG60484QX9) 		OMEPRAZOLE10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
MANNITOL(UNII: 3OWL53L36A)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POVIDONE K30(UNII: U725QWY32X)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color PINK (opaque), BROWN (reddish brown) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code APO;010
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-061-3030 in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
2NDC:63187-061-6060 in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
3NDC:63187-061-9090 in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
4NDC:63187-061-72120 in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
5NDC:63187-061-78180 in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076048 11/11/2003
OmeprazoleOmeprazole CAPSULE, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-070(NDC:60505-0065)
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
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
MANNITOL(UNII: 3OWL53L36A)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POVIDONE K30(UNII: U725QWY32X)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color PINK (opaque), BROWN (reddish brown) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-070-1414 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
2NDC:63187-070-3030 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
3NDC:63187-070-6060 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
4NDC:63187-070-9090 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
5NDC:63187-070-72120 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
6NDC:63187-070-78180 in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076048 11/11/2003

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(63187-061, 63187-070), RELABEL(63187-061, 63187-070)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg BOTTLE

63187-061-60

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 20 mg BOTTLE

63187-070-30