FDA.reportPublic FDA data

Application 076515

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076515-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076515-001AB

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 22:54:322026-06A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076515-001AB1a50c72e98297…

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
OmeprazoleOMEPRAZOLESandoz Inc5a09ce48-7139-4fc7-9b6e-439459c8e8662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076515
application number: ANDA076515
ndc (product): 0781-2234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2234OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2234OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2234OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2234OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2234OmeprazoleOmeprazoleSandoz IncANDACurrent
0904-6144OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
0904-6144OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
55154-7277OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-7277OmeprazoleOmeprazoleCardinal HealthANDACurrent
70518-1261OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1261OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1261OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1261OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1261OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70934-336OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-336OmeprazoleOmeprazoleDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent