omeprazole

Generic: omeprazole

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler remedyrepack inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3278
Product ID 70518-3278_3a7006bf-8a2c-ee86-e063-6294a90a6e48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212977
Listing Expiration 2026-12-31
Marketing Start 2021-11-29

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183278
Hyphenated Format 70518-3278

Supplemental Identifiers

RxCUI
198051
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omeprazole (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA212977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-0)
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-4)
source: ndc

Packages (3)

70518-3278-0 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-0) 70518-3278-3 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-3) 70518-3278-4 60 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-4)

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a7006bf-8a2c-ee86-e063-6294a90a6e48", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["ded0df8b-1813-4595-ac2b-5499704bfd48"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-0)", "package_ndc": "70518-3278-0", "marketing_start_date": "20211129"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-3)", "package_ndc": "70518-3278-3", "marketing_start_date": "20240515"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-3278-4)", "package_ndc": "70518-3278-4", "marketing_start_date": "20240516"}], "brand_name": "Omeprazole", "product_id": "70518-3278_3a7006bf-8a2c-ee86-e063-6294a90a6e48", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70518-3278", "generic_name": "Omeprazole", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA212977", "marketing_category": "ANDA", "marketing_start_date": "20211129", "listing_expiration_date": "20261231"}