Home NDC 70518-1261 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076515-001 OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2009-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076515-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A076515-001 OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2009-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076515-001 AB 1 a50c72e98297…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 70518-1261-0 2022-02-02 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-1 2022-02-02 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-2 2022-02-02 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-3 2022-02-02 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-4 2022-02-02 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-0 2022-01-28 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-1 2022-01-28 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-2 2022-01-28 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-3 2022-01-28 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 70518-1261-4 2022-01-28 C162847 48780-1 d6a99b39-8083-a426-e053-dadaa90af4c2 These 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 NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-1261-3 70518126103 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-3) 2020-09-08 0000-00-00 No No Current 70518-1261-4 70518126104 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1261-4) 2020-12-23 0000-00-00 No No Current