Home NDC 13107-117-42 Omeprazole and Sodium Bicarbonate
Product NDC 13107-117
Requested package NDC 13107-117-42
11-digit product format 131070117
Labeler code 13107
Product ID 13107-117_1f2db15b-a212-4eff-9cad-c971a5a89da4
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole and Sodium Bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA204923
Marketing category ANDA
Marketing start 2014-09-30
Marketing end 0000-00-00
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20 mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07
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 · 41 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 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204923-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL 2016-11-07 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-117 OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC] 2 Legacy NDC 20190912_bfaf1e69-cbe9-4dde-8f65-6e730f47120a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13107-117-42 13107011742 3 BOTTLE in 1 CARTON (13107-117-42) > 14 CAPSULE in 1 BOTTLE 3 bottle 2014-09-30 0000-00-00 No No Current