Home NDC 72288-564-03 omeprazole and sodium bicarbonate
Product NDC 72288-564
Requested package NDC 72288-564-03
11-digit product format 722880564
Labeler code 72288
Product ID 72288-564_65cd8a3c-cab0-4e4c-99ab-74f28cd0202b
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole, sodium bicarbonate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Amazon.com Services LLC
Application ANDA201361
Marketing category ANDA
Marketing start 2026-08-19
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20; 1100 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 caaa826d4ba7…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…
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 Ingredient Strength OMEPRAZOLE 20 mg/1 SODIUM BICARBONATE 1100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KG60484QX9 Internal UNII lookup 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616539 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join omeprazole and sodium bicarbonate OMEPRAZOLE, SODIUM BICARBONATE Amazon.com Services LLC bb453f26-c7df-4cce-8793-337cb5d5f9a9 2026-08-19 Warnings Exact identifier application applno (ANDA): 201361 application number: ANDA201361 ndc (package): 72288-564-03 ndc (product): 72288-564 ndc11 (package): 72288056403 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72288-564-03 72288056403 3 BOTTLE in 1 CARTON (72288-564-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (72288-564-00) 3 bottle 2026-08-19 No No Current