NDC Code(s) : 35356-891-60
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OmeprazoleOmeprazole CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-891(NDC:55111-159)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9) 		OMEPRAZOLE40 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MEGLUMINE(UNII: 6HG8UB2MUY)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLOXAMER 124(UNII: 1S66E28KXA)
POVIDONE(UNII: FZ989GH94E)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color WHITE (off white to pale yellow) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code Omeprazole;40;mg;R159
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-891-6060 in 1 BOTTLE Type 0: Not a Combination Product18/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075576 10/13/2010

PRINCIPAL DISPLAY PANEL

Image of Label