FDA.reportPublic FDA data

Application 203345

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATECAPSULE;ORAL20MG;1.1GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203345-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2018-03-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A203345-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2018-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203345-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2018-03-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203345-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2018-03-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203345-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2018-03-16a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsName fallback
brand name: omeprazole and sodium bicarbonate
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsName fallback
brand name: OMEPRAZOLE AND SODIUM BICARBONATE
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsName fallback
brand name: Omeprazole and sodium bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATECVS Pharmacy186732a3-13b9-4ea2-ba54-424f63298a2e2025-11-04WarningsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEH E Bddc8d73f-f4a1-42a7-89ee-420346820f612025-11-03WarningsName fallback
brand name: Omeprazole and sodium bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsName fallback
brand name: omeprazole and sodium bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEScieGen Pharmaceuticals, Inc.a107804e-b308-4e79-9447-07d93016f70f2024-10-24Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsName fallback
brand name: Omeprazole and Sodium Bicarbonate
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsName fallback
brand name: Omeprazole and Sodium Bicarbonate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-503omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateCadila Healthcare LimitedANDACurrent
70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateZydus Lifesciences LimitedANDACurrent
70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateCadila Healthcare LimitedANDACurrent
70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateCadila Healthcare LimitedANDACurrent
70771-1337omeprazole and sodium bicarbonateomeprazole and sodium bicarbonateCadila Healthcare LimitedANDACurrent