Home NDC 82632-699-01 Zegerid OTC
Product NDC 82632-699
Requested package NDC 82632-699-01
11-digit product format 826320699
Labeler code 82632
Product ID 82632-699_0ed3bd00-7540-4d45-ba18-ccdd0135ada2
Type HUMAN OTC DRUG
Nonproprietary name omepraole, sodium bicarbonate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Riley Consumer Care LLC
Application ANDA201361
Marketing category ANDA
Marketing start 2024-01-10
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20; 1100 mg/1; mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 1 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 2026-10-15 13:18:30 2026-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201361-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-07-15 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zegerid OTC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 20 mg/1 SODIUM BICARBONATE 1100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82632-699-01 Zegerid OTC 1 in 1 CARTON CAPSULE, GELATIN COATED 1 2 82632-699-01 Zegerid OTC 14 in 1 BOTTLE CAPSULE, GELATIN COATED 14 2 82632-699-03 Zegerid OTC 14 in 1 BOTTLE CAPSULE, GELATIN COATED 14 2 82632-699-03 Zegerid OTC 3 in 1 CARTON CAPSULE, GELATIN COATED 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82632-699 ZEGERID OTC (OMEPRAOLE, SODIUM BICARBONATE) CAPSULE, GELATIN COATED [RILEY CONSUMER CARE LLC] 1 Current NDC, 4 package rows 20240206_8d00c19a-d86b-4a2f-8791-b320ad3ca781.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 · 7 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82632-699-01 82632069901 1 BOTTLE in 1 CARTON (82632-699-01) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2024-01-10 No No Current