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
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