Omeprazole

Product NDC
70518-1261
11-digit product format
705181261
Labeler code
70518
Product ID
70518-1261_e3b0f501-baa5-fd39-e053-2a95a90aed98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076515
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-1261DDiscontinued by firm2026-08-03
excluded packagepackage70518-126170518-1261-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-126170518-1261-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-126170518-1261-2DDiscontinued by firm2026-08-03
excluded packagepackage70518-126170518-1261-3DDiscontinued by firm2026-08-03
excluded packagepackage70518-126170518-1261-4DDiscontinued by firm2026-08-03

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1261-02022-02-02C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-12022-02-02C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-22022-02-02C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-32022-02-02C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-42022-02-02C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-02022-01-28C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-12022-01-28C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-22022-01-28C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-32022-01-28C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
70518-1261-42022-01-28C16284748780-1d6a99b39-8083-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1261-37051812610310 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-3) 2020-09-080000-00-00NoNoCurrent
70518-1261-47051812610430 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-4) 2020-12-230000-00-00NoNoCurrent