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
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
Active Moieties
OMEPRAZOLE
Code: KG60484QX9