Home NDC 68682-990 Omeprazole and Sodium Bicarbonate
Product NDC 68682-990
11-digit product format 686820990
Labeler code 68682
Product ID 68682-990_342c0d17-867e-d8da-e063-6394a90a3151
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omeprazole, sodium bicarbonate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA021636
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2004-06-15
Marketing end 2026-08-31
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20; 1680 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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021636-001 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-06-15 N021636-002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-12-21
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 · 84 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 2026-08-18 06:07:40 2026-07 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-06-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-06-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION / ORAL RLD 2004-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-06-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL RLD 2004-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD 2004-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2004-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD 2004-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2004-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD 2004-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2004-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD 2004-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2004-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021636-001 ZEGERID 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD 2004-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021636-002 ZEGERID 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2004-12-21 bb7c543d1eb4…
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 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 20 mg/1 SODIUM BICARBONATE 1680 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 68682-990-30 Omeprazole and Sodium Bicarbonate 30 in 1 CARTON POWDER, FOR SUSPENSION 30 14 68682-990-30 Omeprazole and Sodium Bicarbonate 1 in 1 PACKET POWDER, FOR SUSPENSION 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-990 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, 2 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 · 3 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 68682-990-30 68682099030 30 PACKET in 1 CARTON (68682-990-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET 30 packet 2004-06-15 2026-08-31 No No Current