MedPath
FDA Product

Omeprazole

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

Basic Information

Omeprazole

55111-159

Regulatory Information

55111-159

ANDA075576

C73584

April 20, 2023

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

27

Company Information

650562841

Active Ingredients

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

silicon dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

butyl alcohol

Code: 8PJ61P6TS3

Class Code: IACT

D&C YELLOW NO. 10 ALUMINUM LAKE

Code: CQ3XH3DET6

Class Code: IACT

FD&C BLUE NO. 1 ALUMINUM LAKE

Code: J9EQA3S2JM

Class Code: IACT

FD&C BLUE NO. 2--ALUMINUM LAKE

Code: 4AQJ3LG584

Class Code: IACT

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C Red No. 40

Code: WZB9127XOA

Class Code: IACT

methacrylic acid - ethyl acrylate copolymer (1:1) type A

Code: NX76LV5T8J

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

povidone

Code: FZ989GH94E

Class Code: IACT

triethyl citrate

Code: 8Z96QXD6UM

Class Code: IACT

D&C Red No. 28

Code: 767IP0Y5NH

Class Code: IACT

hypromelloses

Code: 3NXW29V3WO

Class Code: IACT

mannitol

Code: 3OWL53L36A

Class Code: IACT

meglumine

Code: 6HG8UB2MUY

Class Code: IACT

shellac

Code: 46N107B71O

Class Code: IACT

poloxamer 407

Code: TUF2IVW3M2

Class Code: IACT

Omeprazole

Quantity: 40 mg in 1 1

Code: KG60484QX9

Class Code: ACTIB

crospovidone

Code: 68401960MK

Class Code: IACT

FD&C Yellow No. 6

Code: H77VEI93A8

Class Code: IACT

ferric oxide yellow

Code: EX438O2MRT

Class Code: IACT

gelatin

Code: 2G86QN327L

Class Code: IACT

Active Moieties

omeprazole

Code: KG60484QX9

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