MedPath
FDA Product

Omeprazole

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Omeprazole

51655-061

Regulatory Information

51655-061

ANDA075576

C73584

December 31, 2021

USA

These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. INITIAL U.S. APPROVAL: 1989

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

036986393

Active Ingredients

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

MEGLUMINE

Code: 6HG8UB2MUY

Class Code: IACT

OMEPRAZOLE

Quantity: 20 mg in 1 1

Code: KG60484QX9

Class Code: ACTIB

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Code: NX76LV5T8J

Class Code: IACT

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

OMEPRAZOLE

Code: KG60484QX9

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