omeprazole

Generic: omeprazole

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0415
Product ID 80425-0415_1d4ed9f8-bfc9-db89-e063-6394a90ae645
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075576
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

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 804250415
Hyphenated Format 80425-0415

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 ANDA075576 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-1)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-2)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-3)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-4)
source: ndc

Packages (4)

80425-0415-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-1) 80425-0415-2 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-2) 80425-0415-3 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-3) 80425-0415-4 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-4)

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": "1d4ed9f8-bfc9-db89-e063-6394a90ae645", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["1d4ecc1e-5180-f75e-e063-6394a90a51a6"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-1)", "package_ndc": "80425-0415-1", "marketing_start_date": "20240715"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-2)", "package_ndc": "80425-0415-2", "marketing_start_date": "20240715"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-3)", "package_ndc": "80425-0415-3", "marketing_start_date": "20240715"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0415-4)", "package_ndc": "80425-0415-4", "marketing_start_date": "20240715"}], "brand_name": "Omeprazole", "product_id": "80425-0415_1d4ed9f8-bfc9-db89-e063-6394a90ae645", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "80425-0415", "generic_name": "Omeprazole", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA075576", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}