MedPath
FDA Product

Omeprazole

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

Basic Information

Omeprazole

62135-530

Regulatory Information

62135-530

ANDA075410

C73584

March 21, 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, USP. OMEPRAZOLE Delayed-Release Capsules USP Initial U.S. Approval: 1989

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Chartwell RX, LLC

079394054

Active Ingredients

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL

Code: PGG6VG42HP

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

OMEPRAZOLE

Quantity: 10 mg in 1 1

Code: KG60484QX9

Class Code: ACTIB

Active Moieties

OMEPRAZOLE

Code: KG60484QX9

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