Home NDC 68012-102 ZEGERID
Product NDC 68012-102
11-digit product format 680120102
Labeler code 68012
Product ID 68012-102_00549015-8d70-46e3-b7a7-5993e6d858ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omeprazole and sodium bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Santarus, Inc..
Application NDA021849
Marketing category NDA
Marketing start 2006-02-27
Marketing end 0000-00-00
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20 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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 N021849-002 ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27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 · 88 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 2026-10-15 13:18:30 2026-09 N021849-001 ZEGERID 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021849-002 ZEGERID 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2006-02-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021849-001 ZEGERID 20MG;1.1GM **Federal Register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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68012-102-30 ZEGERID 30 in 1 BOTTLE CAPSULE 30 53
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 BICARBONATE ION ACTIVE MOIETY HN1ZRA3Q20 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 SUCROSE INACTIVE INGREDIENT C151H8M554 ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E ZEGERID (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZIOLE, SODIUM BICARBONATE) CAPSULE [SANTARUS, INC.] 32
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68012-102 ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..] 52 Legacy NDC, 1 package rows 20230729_cd6868b9-5824-442b-8d65-4db29ecb70a4.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 616539 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Zegerid 40 MG / 1100 MG Oral Capsule, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 PSN cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SBD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616539 omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension SCD cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616539 Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753562 Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 616541 Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753557 Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral Suspension [Zegerid Reformulated Aug 2006] SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid (omeprazole 20 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid (omeprazole 40 MG / sodium bicarbonate 1680 MG) Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753603 Zegerid 20 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 753601 Zegerid 40 MG / 1680 MG Powder for Oral Suspension, Reformulated Aug 2006 SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646344 Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53 646352 Zegerid Reformulated Aug 2006 (omeprazole 40 MG / sodium bicarbonate 1100 MG) Oral Capsule SY cd6868b9-5824-442b-8d65-4db29ecb70a4 53
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68012-102-30 68012010230 30 CAPSULE in 1 BOTTLE (68012-102-30) 30 capsule 2006-02-27 0000-00-00 No No Current