omeprazole

Generic: omeprazole

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-023
Product ID 82009-023_8aee798c-2e69-76b9-85b5-3a4e0a0c7a94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

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 82009023
Hyphenated Format 82009-023

Supplemental Identifiers

RxCUI
198051 200329
UPC
0382009023052 0382009183107
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 ANDA078490 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05)
source: ndc

Packages (1)

82009-023-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05)

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": "8aee798c-2e69-76b9-85b5-3a4e0a0c7a94", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0382009023052", "0382009183107"], "unii": ["KG60484QX9"], "rxcui": ["198051", "200329"], "spl_set_id": ["8090d4c3-3184-7812-53d7-aa30e14b79d1"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-023-05)", "package_ndc": "82009-023-05", "marketing_start_date": "20221115"}], "brand_name": "Omeprazole", "product_id": "82009-023_8aee798c-2e69-76b9-85b5-3a4e0a0c7a94", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82009-023", "generic_name": "Omeprazole", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA078490", "marketing_category": "ANDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}