FDA.reportPublic FDA data

Omeprazole and Sodium Bicarbonate

Product NDC
68682-991
Requested package NDC
68682-991-30
11-digit product format
686820991
Labeler code
68682
Product ID
68682-991_a52d487d-f07a-42f9-998c-c68fa2e1d9c7
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
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
40 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68682-99168682-991-30DDiscontinued by firm2026-07-31

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SODIUM BICARBONATE20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-06-15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SODIUM BICARBONATE40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-12-21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

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021636-001ZEGERID20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-06-15a50c72e98297…
2026-08-01 22:54:322026-06N021636-002ZEGERID40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD2004-12-21a50c72e98297…

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 · 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 (package): 68682-991-30
ndc (product): 68682-991
ndc11 (package): 68682099130
ZEGERIDOMEPRAZOLE AND SODIUM BICARBONATESantarus, Inc..cd6868b9-5824-442b-8d65-4db29ecb70a42023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021636
application number: NDA021636

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
68682-991-30Omeprazole and Sodium Bicarbonate30 in 1 CARTONPOWDER, FOR SUSPENSION3014
68682-991-30Omeprazole and Sodium Bicarbonate1 in 1 PACKETPOWDER, FOR SUSPENSION114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-991OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [OCEANSIDE PHARMACEUTICALS]14Legacy NDC, 2 package rows20250504_c26b6893-8264-4d4a-ac7e-1ddda933451e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
68682-991-306868209913030 PACKET in 1 CARTON (68682-991-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2004-06-150000-00-00NoNoCurrent