MedPath
FDA Product

Omeprazole

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

Basic Information

Omeprazole

55111-644

Regulatory Information

55111-644

ANDA078490

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

29

Company Information

650562841

Active Ingredients

Omeprazole

Quantity: 20 mg in 1 1

Code: KG60484QX9

Class Code: ACTIB

glyceryl monostearate

Code: 230OU9XXE4

Class Code: IACT

meglumine

Code: 6HG8UB2MUY

Class Code: IACT

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

Code: NX76LV5T8J

Class Code: IACT

RAW SUGAR

Code: 8M707QY5GH

Class Code: IACT

POLOXAMER 407

Code: TUF2IVW3M2

Class Code: IACT

talc

Code: 7SEV7J4R1U

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

D&C Red No. 28

Code: 767IP0Y5NH

Class Code: IACT

triethyl citrate

Code: 8Z96QXD6UM

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

gelatin

Code: 2G86QN327L

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

hypromelloses

Code: 3NXW29V3WO

Class Code: IACT

Active Moieties

Omeprazole

Code: KG60484QX9

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