Home NDC 53041-664 Omeprazole, Sodium bicarbonate
Product NDC 53041-664
11-digit product format 530410664
Labeler code 53041
Product ID 53041-664_27536955-37df-4dcc-ad75-2b364fe95460
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole, Sodium bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Guardian Drug Company
Application ANDA212587
Marketing category ANDA
Marketing start 2020-05-07
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20; 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 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 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 76 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 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212587-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2020-04-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212587-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2020-04-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Omeprazole, Sodium bicarbonate
Listing expiration 2026-12-31 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 8MDF5V39QO Internal UNII lookup KG60484QX9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616539 Internal RxNorm lookup 616541 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 53041-664-77 Omeprazole, Sodium bicarbonate 30 in 1 BOTTLE CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-664 OMEPRAZOLE, SODIUM BICARBONATE CAPSULE [GUARDIAN DRUG COMPANY] 6 Current NDC, Legacy NDC, 1 package rows 20221110_e5c6c2cf-fb3b-456a-a0a0-be396d6f8319.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 · 1 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 53041-664-77 53041066477 30 CAPSULE in 1 BOTTLE (53041-664-77) 30 capsule 2020-05-07 0000-00-00 No No Current