omeprazole

Generic: omeprazole

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

omeprazole 40 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-879
Product ID 76420-879_2dfff480-dff9-b242-e063-6394a90a1fcf
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 76420879
Hyphenated Format 76420-879

Supplemental Identifiers

RxCUI
198051 199119 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 (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
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-00)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-01)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-03)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-06)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-09)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-12)
source: ndc

Packages (6)

76420-879-00 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-00) 76420-879-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-01) 76420-879-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-03) 76420-879-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-06) 76420-879-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-09) 76420-879-12 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-12)

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": "2dfff480-dff9-b242-e063-6394a90a1fcf", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-00)", "package_ndc": "76420-879-00", "marketing_start_date": "20241203"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-01)", "package_ndc": "76420-879-01", "marketing_start_date": "20241203"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-03)", "package_ndc": "76420-879-03", "marketing_start_date": "20241203"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-06)", "package_ndc": "76420-879-06", "marketing_start_date": "20241203"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-09)", "package_ndc": "76420-879-09", "marketing_start_date": "20241203"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-12)", "package_ndc": "76420-879-12", "marketing_start_date": "20250121"}], "brand_name": "Omeprazole", "product_id": "76420-879_2dfff480-dff9-b242-e063-6394a90a1fcf", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-879", "generic_name": "Omeprazole", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA091672", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}