omeprazole

Generic: omeprazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-482
Product ID 72789-482_402ff545-7931-7f7d-e063-6394a90a9e5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2026-12-31
Marketing Start 2014-03-01

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 72789482
Hyphenated Format 72789-482

Supplemental Identifiers

RxCUI
198051
UPC
0372789482903
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 ANDA078490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-14)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-90)
source: ndc

Packages (4)

72789-482-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-14) 72789-482-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-30) 72789-482-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-60) 72789-482-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-90)

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": "402ff545-7931-7f7d-e063-6394a90a9e5a", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0372789482903"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["96104ea6-c08f-40b5-83f5-d840b317f1fd"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-14)", "package_ndc": "72789-482-14", "marketing_start_date": "20250507"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-30)", "package_ndc": "72789-482-30", "marketing_start_date": "20250125"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-60)", "package_ndc": "72789-482-60", "marketing_start_date": "20250320"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-482-90)", "package_ndc": "72789-482-90", "marketing_start_date": "20250123"}], "brand_name": "Omeprazole", "product_id": "72789-482_402ff545-7931-7f7d-e063-6394a90a9e5a", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "72789-482", "generic_name": "Omeprazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA078490", "marketing_category": "ANDA", "marketing_start_date": "20140301", "listing_expiration_date": "20261231"}