FDA.reportPublic FDA data

OMEPRAZOLE AND SODIUM BICARBONATE

Product NDC
58602-732
11-digit product format
586020732
Labeler code
58602
Product ID
58602-732_224fe1a6-84e4-41eb-a328-1349f687f7f3
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE AND SODIUM BICARBONATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA204923
Marketing category
ANDA
Marketing start
2026-09-22
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 1100 mg/1; mg/1
Pharmacologic classes
Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07c2088c7a36db…
2026-09-14 22:38:342026-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
OMEPRAZOLE AND SODIUM BICARBONATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1
SODIUM BICARBONATE1100 mg/1

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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-732-05586020732051 BOTTLE in 1 CARTON (58602-732-05) / 14 CAPSULE in 1 BOTTLE1 bottle2026-09-22NoNoCurrent
58602-732-57586020732572 BOTTLE in 1 CARTON (58602-732-57) / 14 CAPSULE in 1 BOTTLE2 bottle2026-09-22NoNoCurrent
58602-732-60586020732603 BOTTLE in 1 CARTON (58602-732-60) / 14 CAPSULE in 1 BOTTLE3 bottle2026-09-22NoNoCurrent