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
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