Home Applications 201361 Application 201361
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL 20MG;1.1GM No No
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-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 2 of 2 · 44 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 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a50c72e98297…
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 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 ndc (product): 79903-013 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 ndc (product): 0363-0732 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 ndc (product): 59779-732 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 ndc (product): 72288-732 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 ndc (product): 37808-732 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 ndc (product): 41250-938 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 ndc (product): 0113-0058
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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0058 Good Sense Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate L. Perrigo Company ANDA Current 0113-0058 Good Sense Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate L. Perrigo Company ANDA Current 0363-0732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Walgreen Company ANDA Current 0363-0732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Walgreen Company ANDA Current 0363-0732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Walgreen Company ANDA Current 11523-7276 Zegerid OTC omeprazole and sodium bicarbonate Bayer HealthCare LLC. ANDA Current 11523-7276 Zegerid OTC omeprazole and sodium bicarbonate Bayer HealthCare LLC. ANDA Current 11523-7276 Zegerid OTC omeprazole and sodium bicarbonate Bayer HealthCare LLC. ANDA Current 36800-732 topcare omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Topco Associates LLC ANDA Current 37808-732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate H E B ANDA Current 37808-732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate H E B ANDA Current 37808-732 Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate H E B ANDA Current 41250-938 omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Meijer Distribution Inc ANDA Current 41250-938 omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Meijer Distribution Inc ANDA Current 41250-938 omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Meijer Distribution Inc ANDA Current 59779-732 Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate CVS Pharmacy ANDA Current 59779-732 Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate CVS Pharmacy ANDA Current 59779-732 Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate CVS Pharmacy ANDA Current 72288-732 basic care omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Amazon.com Services LLC ANDA Current 79903-013 equate omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate Wal-Mart Stores Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 19014 ORIG 2016-07-21 9887 ORIG 2016-07-20