Omeprazole and Sodium Bicarbonate

Product NDC
68682-990
11-digit product format
686820990
Labeler code
68682
Product ID
68682-990_342c0d17-867e-d8da-e063-6394a90a3151
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole, sodium bicarbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021636
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2004-06-15
Marketing end
2026-08-31
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20; 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
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021636-001ZEGERIDOMEPRAZOLE; SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-06-15
N021636-002ZEGERIDOMEPRAZOLE; SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-12-21

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021636-001ZEGERID20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021636-002ZEGERID40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021636-001ZEGERID20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021636-002ZEGERID40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-06-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALRLD2004-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD2004-06-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD, RS2004-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD2004-06-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD, RS2004-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD2004-06-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD, RS2004-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD2004-06-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD, RS2004-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021636-001ZEGERID20MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD2004-06-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021636-002ZEGERID40MG/PACKET;1.68GM/PACKETFOR SUSPENSION / ORALABRLD, RS2004-12-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021636-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021636-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021636-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021636-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021636-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021636-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021636-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021636-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021636-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021636-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021636-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021636-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021636-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021636-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021636-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021636-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021636-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021636-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021636-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021636-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021636-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N021636-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021636-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021636-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021636-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021636-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021636-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021636-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021636-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021636-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021636-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021636-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021636-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021636-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021636-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021636-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021636-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021636-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021636-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021636-002AB13f0d92c62455…

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole and Sodium Bicarbonate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 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
KG60484QX9Internal UNII lookup
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616539Internal RxNorm lookup
616541Internal RxNorm lookup
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
c26b6893-8264-4d4a-ac7e-1ddda933451eAvailable 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
68682-990-30Omeprazole and Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION3014
68682-990-30Omeprazole and Sodium Bicarbonate1 in 1 PACKETPOWDER, FOR SUSPENSION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-990OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS]14Current NDC, Legacy NDC, 2 package rows20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEBryant Ranch Prepack0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb952025-06-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 021636
application number: NDA021636
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEOceanside Pharmaceuticalsc26b6893-8264-4d4a-ac7e-1ddda933451e2025-05-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021636
application number: NDA021636
ndc (product): 68682-990
ZEGERIDOMEPRAZOLE AND SODIUM BICARBONATESantarus, Inc..cd6868b9-5824-442b-8d65-4db29ecb70a42023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021636
application number: NDA021636

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSN0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCD0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSY0b1ec3e1-8489-4738-b5c8-9dfa5d8ebb95101
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsulePSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionPSNc26b6893-8264-4d4a-ac7e-1ddda933451e14
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541omeprazole 40 MG / sodium bicarbonate 1100 MG Oral CapsuleSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557omeprazole 40 MG / sodium bicarbonate 1680 MG Powder for Oral SuspensionSCDc26b6893-8264-4d4a-ac7e-1ddda933451e14
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
753562Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
616541Omeprazole 40 MG / NaHCO3 1100 MG Oral CapsuleSYc26b6893-8264-4d4a-ac7e-1ddda933451e14
753557Omeprazole 40 MG / NaHCO3 1680 MG Powder for Oral SuspensionSYc26b6893-8264-4d4a-ac7e-1ddda933451e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-990-306868209903030 PACKET in 1 CARTON (68682-990-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2004-06-152026-08-31NoNoCurrent