FDA.reportPublic FDA data

omeprazole/sodium bicarbonate

Product NDC
66993-412
Requested package NDC
66993-412-30
11-digit product format
669930412
Labeler code
66993
Product ID
66993-412_091bd0ba-b3a9-4cfe-b680-ae8ff1f105e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole, sodium bicarbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021849
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-02-27
Marketing end
0000-00-00
Substance
OMEPRAZOLE; SODIUM BICARBONATE
Active strength
20 mg/1; mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage66993-41266993-412-30DDiscontinued 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
N021849-001ZEGERIDOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-02-27
N021849-002ZEGERIDOMEPRAZOLE; SODIUM BICARBONATE40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-02-27

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 22:54:322026-06N021849-001ZEGERID20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-02-27a50c72e98297…
2026-08-01 22:54:322026-06N021849-002ZEGERID40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2006-02-27a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEOceanside Pharmaceuticalsc26b6893-8264-4d4a-ac7e-1ddda933451e2025-05-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021849
application number: NDA021849
ZEGERIDOMEPRAZOLE AND SODIUM BICARBONATESantarus, Inc..cd6868b9-5824-442b-8d65-4db29ecb70a42023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021849
application number: NDA021849

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-412-30EA - Each66993-412af286020-9749-4605-b8bf-2780c391079812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
omeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13
sodium bicarbonateACTIVE INGREDIENT8MDF5V39QOOMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13
bicarbonate ionACTIVE MOIETYHN1ZRA3Q20OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UIOMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [PRASCO, LABORATORIES]13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-412-306699304123030 CAPSULE in 1 BOTTLE (66993-412-30) 30 capsule2006-02-270000-00-00NoNoCurrent