Omeprazole and Sodium Bicarbonate

Product NDC
27241-030
11-digit product format
272410030
Labeler code
27241
Product ID
27241-030_e627be01-7cc1-4a03-a183-1a5cfe92f9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole and Sodium Bicarbonate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA205545
Marketing category
ANDA
Marketing start
2016-07-27
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40; 1680 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
2027-12-31
Current FDA listing
Yes

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
A205545-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27
A205545-002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205545-001AB
A205545-002AB

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 UTC2026-02A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRS2016-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205545-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A205545-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2016-07-27782e0a99824c…

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 UTC2026-02A205545-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205545-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205545-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205545-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205545-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205545-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205545-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205545-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205545-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205545-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205545-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205545-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205545-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205545-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205545-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205545-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205545-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205545-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205545-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205545-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205545-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205545-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205545-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205545-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205545-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205545-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205545-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205545-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205545-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205545-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205545-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205545-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205545-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205545-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205545-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205545-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205545-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205545-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205545-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205545-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1
SODIUM BICARBONATE1680 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
753557Internal RxNorm lookup
753562Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd84ca00-6352-4cb3-bce2-05f4a5005a94Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-030-31Omeprazole and Sodium Bicarbonate30 in 1 CARTONFOR SUSPENSION3014
27241-030-62Omeprazole and Sodium Bicarbonate1 in 1 PACKETFOR SUSPENSION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-030-31EA - Each27241-0303239b856-4de6-47f1-85b2-60d4029a2dc812016-11-08
27241-030-62EA - Each27241-0302279bea0-0234-4e27-b624-229d79f2e4c812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-030OMEPRAZOLE AND SODIUM BICARBONATE FOR SUSPENSION [AJANTA PHARMA USA INC.]13Current NDC, Legacy NDC, 2 package rows20240911_bd84ca00-6352-4cb3-bce2-05f4a5005a94.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205545
application number: ANDA205545
ndc (product): 27241-030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYbd84ca00-6352-4cb3-bce2-05f4a5005a9414
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYbd84ca00-6352-4cb3-bce2-05f4a5005a9414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-030-312724100303130 FOR SUSPENSION in 1 CARTON (27241-030-31) 30 for suspension2016-07-270000-00-00NoNoCurrent
27241-030-62272410030621 FOR SUSPENSION in 1 PACKET (27241-030-62) 1 for suspension2016-07-270000-00-00NoNoCurrent