omeprazole dr

Generic: omeprazole

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

Drug Facts

Product Profile

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

omeprazole 40 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0169
Product ID 80425-0169_2a99a670-af31-299d-e063-6294a90a05d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091672
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

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 804250169
Hyphenated Format 80425-0169

Supplemental Identifiers

RxCUI
200329
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 dr (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA091672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-1)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-2)
source: ndc

Packages (2)

80425-0169-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-1) 80425-0169-2 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-2)

Ingredients (1)

omeprazole (40 mg/1)

Linked Drug Pages (1)

Omeprazole DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a99a670-af31-299d-e063-6294a90a05d2", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["c8bf92c9-1bab-7985-e053-2995a90a0225"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-1)", "package_ndc": "80425-0169-1", "marketing_start_date": "20141031"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-2)", "package_ndc": "80425-0169-2", "marketing_start_date": "20141031"}], "brand_name": "Omeprazole DR", "product_id": "80425-0169_2a99a670-af31-299d-e063-6294a90a05d2", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "80425-0169", "generic_name": "Omeprazole", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "brand_name_suffix": "DR", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA091672", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}