Basic Information
Omeprazole and Sodium Bicrabonate
55111-364
Regulatory Information
55111-364
ANDA204068
C73584
March 20, 2022
USA
These highlights do not include all the information needed to use OMEPRAZOLE and SODIUM BICARBONATE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE and SODIUM BICARBONATE CAPSULES. OMEPRAZOLE and SODIUM BICARBONATE c apsules, for oral use Initial U.S. Approval: 2004
HUMAN PRESCRIPTION DRUG LABEL
11
Company Information
650562841
Active Ingredients
Inactive Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
silicon dioxide
Code: ETJ7Z6XBU4
Class Code: IACT
sodium stearyl fumarate
Code: 7CV7WJK4UI
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
Potassium hydroxide
Code: WZH3C48M4T
Class Code: IACT
propylene glycol
Code: 6DC9Q167V3
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
shellac
Code: 46N107B71O
Class Code: IACT
ammonia
Code: 5138Q19F1X
Class Code: IACT
gelatin
Code: 2G86QN327L
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
Active Moieties
omeprazole
Code: KG60484QX9
bicarbonate ion
Code: HN1ZRA3Q20