omeprazole

Generic: omeprazole

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler apotex corp
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-0146
Product ID 60505-0146_8619e520-d106-4778-e92a-09b919b55c70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076048
Marketing Start 2009-01-21
Marketing End 2027-01-31

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 605050146
Hyphenated Format 60505-0146

Supplemental Identifiers

RxCUI
198051 199119 200329
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

Packaging Origin

Original Packager
true

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 ANDA076048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-0)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-1)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-2)
source: ndc

Packages (3)

60505-0146-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-0) 60505-0146-1 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-1) 60505-0146-2 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-2)

Ingredients (1)

omeprazole (40 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": "8619e520-d106-4778-e92a-09b919b55c70", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["b83329ac-a65e-b3af-a3fb-c5a6c740e5e7"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-0)", "package_ndc": "60505-0146-0", "marketing_end_date": "20260331", "marketing_start_date": "20090121"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-1)", "package_ndc": "60505-0146-1", "marketing_end_date": "20270131", "marketing_start_date": "20090121"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-2)", "package_ndc": "60505-0146-2", "marketing_end_date": "20270131", "marketing_start_date": "20090121"}], "brand_name": "Omeprazole", "product_id": "60505-0146_8619e520-d106-4778-e92a-09b919b55c70", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "60505-0146", "generic_name": "Omeprazole", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA076048", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20090121"}