Omeprazole/Sodium Bicarbonate

Product NDC
64380-182
11-digit product format
643800182
Labeler code
64380
Product ID
64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA079182
Marketing category
ANDA
Marketing start
2022-10-01
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 1680 mg/1700mg; mg/1700mg
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
2026-12-31
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
A079182-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19
A079182-002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079182-001AB
A079182-002AB

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 UTC2026-02A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19782e0a99824c…

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 UTC2026-02A079182-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079182-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079182-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079182-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079182-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079182-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079182-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079182-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079182-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079182-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079182-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079182-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079182-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079182-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079182-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079182-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079182-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079182-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079182-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079182-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079182-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079182-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079182-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079182-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079182-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079182-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079182-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079182-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079182-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079182-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079182-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079182-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079182-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079182-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079182-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079182-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079182-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079182-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079182-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079182-002AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole/Sodium BicarbonateOMEPRAZOLEStrides Pharma Science Limitedcf6d293e-d70d-443e-8292-d693e93aab552023-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079182
application number: ANDA079182
ndc (product): 64380-182

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole/Sodium Bicarbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1700mg
SODIUM BICARBONATE1680 mg/1700mg

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
cf6d293e-d70d-443e-8292-d693e93aab55Available 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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-182-01Omeprazole/Sodium Bicarbonate20 mg in 1 POUCHPOWDER, FOR SUSPENSION205
64380-182-02Omeprazole/Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-182-01EA - Each64380-18253ebcb29-69d6-4058-ba68-980f8ff31d5912022-10-06
64380-182-02EA - Each64380-1825c866ff3-9208-4017-9eb8-902279deed4912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-182OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE) POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, Legacy NDC, 2 package rows20231213_cf6d293e-d70d-443e-8292-d693e93aab55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcf6d293e-d70d-443e-8292-d693e93aab555
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNcf6d293e-d70d-443e-8292-d693e93aab555
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcf6d293e-d70d-443e-8292-d693e93aab555
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDcf6d293e-d70d-443e-8292-d693e93aab555
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcf6d293e-d70d-443e-8292-d693e93aab555
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYcf6d293e-d70d-443e-8292-d693e93aab555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-182-016438001820120 mg in 1 POUCH20 mgHistorical
64380-182-026438001820230 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01) 30 pouch2022-10-010000-00-00NoNoCurrent