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 43.

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-1984e616aacf4f…
2026-08-18 06:07:402026-07A079182-001OMEPRAZOLE AND SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079182-002OMEPRAZOLE AND SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALAB2013-04-19caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079182-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079182-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A079182-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079182-002AB1caaa826d4ba7…
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…

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

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/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

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