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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13107-11513107-115-30IInactivated by FDA2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204922-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19
A204922-002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204922-001AB
A204922-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204922-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-08-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A204922-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-08-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204922-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204922-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204922-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204922-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204922-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204922-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204922-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204922-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204922-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204922-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204922-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204922-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204922-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204922-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204922-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204922-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204922-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204922-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204922-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204922-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204922-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204922-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204922-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204922-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204922-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204922-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204922-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204922-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204922-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204922-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204922-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204922-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204922-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204922-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204922-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204922-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204922-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204922-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204922-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204922-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-115-05Omeprazole and Sodium Bicarbonate500 in 1 BOTTLECAPSULE5003
13107-115-30Omeprazole and Sodium Bicarbonate30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-115-30EA - Each13107-1152f788a72-9414-4880-8035-cd3f8a15855512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-115OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC]3Legacy NDC, 2 package rows20190912_1e3a3321-fd27-4b56-8690-933d0c8738b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN1e3a3321-fd27-4b56-8690-933d0c8738b93
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSN1e3a3321-fd27-4b56-8690-933d0c8738b93
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD1e3a3321-fd27-4b56-8690-933d0c8738b93
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD1e3a3321-fd27-4b56-8690-933d0c8738b93
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY1e3a3321-fd27-4b56-8690-933d0c8738b93
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSY1e3a3321-fd27-4b56-8690-933d0c8738b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-115-301310701153030 CAPSULE in 1 BOTTLE (13107-115-30) 30 capsule2014-09-300000-00-00NoNoCurrent