Orange Book product · Brand (NDA)
ZEGERID OTC
OMEPRAZOLE; SODIUM BICARBONATE
At a glance
Jun 17, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2013
13 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
OMEPRAZOLE; SODIUM BICARBONATE
Strength
20MG/PACKET;1.68GM/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 022283
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022KONVOMEPBrand (NDA)
NDA 213593 · AZURITY
- 2009ZEGERID OTCBrand (NDA)
NDA 022281 · RILEY CONSUMER
- 2006ZEGERIDBrand (NDA)
NDA 021849 · SALIX
- 2004ZEGERIDBrand (NDA)
NDA 021636 · SALIX
- 2025OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 219161 · NOVITIUM PHARMA
- 2024OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 217784 · DR REDDYS
- 2020OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 212587 · ANDA REPOSITORY
- 2018OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 203290 · ZYDUS PHARMS
- 2018OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 203345 · ZYDUS
- 2016OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 207476 · SCIEGEN PHARMS
- 2016OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 204923 · AUROBINDO PHARMA
- 2016OMEPRAZOLE AND SODIUM BICARBONATEGeneric (ANDA)
ANDA 204922 · AUROLIFE PHARMA LLC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
