Home NDC 13107-115-30 Omeprazole and Sodium Bicarbonate
Product NDC 13107-115
Requested package NDC 13107-115-30
11-digit product format 131070115
Labeler code 13107
Product ID 13107-115_24a89440-1995-44fc-b739-8c9f666efdb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole and Sodium Bicarbonate
Dosage form CAPSULE
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA204922
Marketing category ANDA
Marketing start 2014-09-30
Marketing end 0000-00-00
Substance OMEPRAZOLE; SODIUM BICARBONATE
Active strength 20 mg/1; mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19
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 3 · 82 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 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204922-001 OMEPRAZOLE AND SODIUM BICARBONATE 20MG;1.1GM CAPSULE / ORAL AB 2016-08-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204922-002 OMEPRAZOLE AND SODIUM BICARBONATE 40MG;1.1GM CAPSULE / ORAL AB 2016-08-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-115-05 Omeprazole and Sodium Bicarbonate 500 in 1 BOTTLE CAPSULE 500 3 13107-115-30 Omeprazole and Sodium Bicarbonate 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-115 OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC] 3 Legacy NDC, 2 package rows 20190912_1e3a3321-fd27-4b56-8690-933d0c8738b9.zip
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 13107-115-30 13107011530 30 CAPSULE in 1 BOTTLE (13107-115-30) 30 capsule 2014-09-30 0000-00-00 No No Current