Home NDC 68682-104 Omeprazole and Sodium Bicarbonate
Product NDC 68682-104
11-digit product format 686820104
Labeler code 68682
Product ID 68682-104_342c0d17-867e-d8da-e063-6394a90a3151
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omeprazole, sodium bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA021849
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2006-02-27
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 40; 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021849-001 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 N021849-002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27
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 3 · 82 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UTC 2026-02 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL RLD 2006-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021849-001 ZEGERID 20MG;1.1GM CAPSULE / ORAL AB RLD 2006-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021849-002 ZEGERID 40MG;1.1GM CAPSULE / ORAL AB RLD, RS 2006-02-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Omeprazole and Sodium Bicarbonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 40 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616539 Internal RxNorm lookup 616541 Internal RxNorm lookup 753557 Internal RxNorm lookup 753562 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68682-104-30 Omeprazole and Sodium Bicarbonate 30 in 1 BOTTLE CAPSULE 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-104 OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS] 14 Current NDC, Legacy NDC, 1 package rows 20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.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 · 2 matching rows.
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 68682-104-30 68682010430 30 CAPSULE in 1 BOTTLE (68682-104-30) 30 capsule 2007-02-27 0000-00-00 No No Current