Home NDC 11523-7276 Zegerid OTC
Product NDC 11523-7276
11-digit product format 115237276
Labeler code 11523
Product ID 11523-7276_ef174d5f-22a0-4dd8-e053-2a95a90a2bb8
Type HUMAN OTC DRUG
Nonproprietary name omeprazole and sodium bicarbonate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Bayer HealthCare LLC.
Application ANDA201361
Marketing category ANDA
Marketing start 2017-10-01
Marketing end 0000-00-00
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20 mg/1; mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 cb3db0bc1861…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11523-7276-1 Zegerid OTC 1 in 1 CARTON CAPSULE, GELATIN COATED 1 6 11523-7276-1 Zegerid OTC 14 in 1 BOTTLE CAPSULE, GELATIN COATED 14 6 11523-7276-2 Zegerid OTC 1 in 1 CARTON CAPSULE, GELATIN COATED 1 6 11523-7276-2 Zegerid OTC 42 in 1 BOTTLE CAPSULE, GELATIN COATED 42 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-7276 ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [BAYER HEALTHCARE LLC.] 6 Legacy NDC, 4 package rows 20241208_5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77.zip
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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join equate omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE WALMART INC. c24c3326-99da-4c7d-aecc-7b4a8ac3f04e 2026-03-15 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 Omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE Walgreen Company 8753a131-f8b1-48e1-993b-73c1ee635fef 2025-11-04 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 Omeprazole and Sodium Bicarbonate OMEPRAZOLE, SODIUM BICARBONATE CVS Pharmacy 186732a3-13b9-4ea2-ba54-424f63298a2e 2025-11-04 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 basic care omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE Amazon.com Services LLC 4587f491-04ef-4c31-b7b6-bfafd31776fb 2025-11-04 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 Omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE H E B ddc8d73f-f4a1-42a7-89ee-420346820f61 2025-11-03 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE Meijer Distribution Inc bb7c1c5d-b915-42f5-a5a2-5f61b088028d 2025-09-05 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 Zegerid OTC OMEPRAOLE, SODIUM BICARBONATE Riley Consumer Care LLC 8d00c19a-d86b-4a2f-8791-b320ad3ca781 2025-07-15 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 Good Sense Omeprazole and Sodium Bicarbonate OMEPRAZOLE, SODIUM BICARBONATE L. Perrigo Company bcf32242-de17-4da1-b707-4ce26262eb78 2020-11-16 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11523-7276-1 11523727601 1 BOTTLE in 1 CARTON (11523-7276-1) > 14 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2017-10-01 0000-00-00 No No Current 11523-7276-2 11523727602 1 BOTTLE in 1 CARTON (11523-7276-2) > 42 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2017-10-01 0000-00-00 No No Current