FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
13107-117
11-digit product format
131070117
Labeler code
13107
Product ID
13107-117_1f2db15b-a212-4eff-9cad-c971a5a89da4
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA204923
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13107-117DDiscontinued by firm2026-08-03
excluded packagepackage13107-11713107-117-14DDiscontinued by firm2026-08-03
excluded packagepackage13107-11713107-117-28DDiscontinued by firm2026-08-03
excluded packagepackage13107-11713107-117-42DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204923-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
application applno (ANDA): 204923
application number: ANDA204923

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-117-142025-12-15C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a
13107-117-282025-12-15C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a
13107-117-422025-12-15C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a
13107-117-142023-01-30C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a
13107-117-282023-01-30C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a
13107-117-422023-01-30C16284748780-1f386c649-c40e-0266-e053-dadaa90a7c1abfaf1e69-cbe9-4dde-8f65-6e730f47120a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-117OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC]2Legacy NDC20190912_bfaf1e69-cbe9-4dde-8f65-6e730f47120a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-117-14131070117141 BOTTLE in 1 CARTON (13107-117-14) > 14 CAPSULE in 1 BOTTLE1 bottle2014-09-300000-00-00NoNoCurrent
13107-117-28131070117282 BOTTLE in 1 CARTON (13107-117-28) > 14 CAPSULE in 1 BOTTLE2 bottle2014-09-300000-00-00NoNoCurrent
13107-117-42131070117423 BOTTLE in 1 CARTON (13107-117-42) > 14 CAPSULE in 1 BOTTLE3 bottle2014-09-300000-00-00NoNoCurrent