Omeprazole/Bicarbonate

Product NDC
69367-195
11-digit product format
693670195
Labeler code
69367
Product ID
69367-195_affcd9b4-a7b0-43be-9e3c-1b82614c3b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207476
Marketing category
ANDA
Marketing start
2018-07-27
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69367-195DDiscontinued by firm2026-08-10
excluded packagepackage69367-19569367-195-30DDiscontinued by firm2026-08-10

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69367-195-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69367-195-30f5e01cc5f278…a2eaf40c39c3…

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
A207476-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06
A207476-002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207476-001AB
A207476-002AB

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 UTC2026-02A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207476-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2016-12-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A207476-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2016-12-06782e0a99824c…

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 UTC2026-02A207476-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207476-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207476-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207476-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207476-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207476-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207476-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207476-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207476-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207476-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207476-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207476-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207476-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207476-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207476-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207476-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207476-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207476-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207476-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207476-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207476-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207476-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207476-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207476-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207476-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207476-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207476-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207476-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207476-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207476-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207476-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207476-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207476-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207476-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207476-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207476-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207476-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207476-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207476-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207476-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-195-30Omeprazole/Bicarbonate30 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-195-30EA - Each69367-195f4c1b576-9384-4fa4-836c-a37139652c5f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-195OMEPRAZOLE/BICARBONATE (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [WESTMINSTER PHARMACEUTICALS, LLC]9Legacy NDC, 1 package rows20250515_d69c2f0f-4e8b-422a-8aaf-a825998b04e0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207476
application number: ANDA207476
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEWestminster Pharmaceuticals, LLCd69c2f0f-4e8b-422a-8aaf-a825998b04e02026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207476
application number: ANDA207476
ndc (product): 69367-195
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEScieGen Pharmaceuticals, Inc.a107804e-b308-4e79-9447-07d93016f70f2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207476
application number: ANDA207476
omeprazole sodium bicarbonateOMEPRAZOLE SODIUM BICARBONATECipla USA Inc.9cdde58a-ae8a-451f-92cf-cab178e4ba922023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207476
application number: ANDA207476

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYd69c2f0f-4e8b-422a-8aaf-a825998b04e010
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN4d642036-7175-4f29-9f07-dbd282231d4a3
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSN4d642036-7175-4f29-9f07-dbd282231d4a3
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD4d642036-7175-4f29-9f07-dbd282231d4a3
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD4d642036-7175-4f29-9f07-dbd282231d4a3
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY4d642036-7175-4f29-9f07-dbd282231d4a3
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSY4d642036-7175-4f29-9f07-dbd282231d4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-195-306936701953030 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (69367-195-30) 2018-07-270000-00-00NoNoCurrent