omeprazole

Generic: omeprazole

Labeler: phoenix rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler phoenix rx llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1644
Product ID 85509-1644_3b19d244-3cd1-0813-e063-6394a90ac153
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078490
Listing Expiration 2026-12-31
Marketing Start 2025-03-06

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 855091644
Hyphenated Format 85509-1644

Supplemental Identifiers

RxCUI
198051
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
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-1)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-6)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-9)
source: ndc

Packages (4)

85509-1644-1 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-1) 85509-1644-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-3) 85509-1644-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-6) 85509-1644-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-9)

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": "3b19d244-3cd1-0813-e063-6394a90ac153", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["3b19d724-821b-61dc-e063-6294a90aa4d3"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-1)", "package_ndc": "85509-1644-1", "marketing_start_date": "20250729"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-3)", "package_ndc": "85509-1644-3", "marketing_start_date": "20250729"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-6)", "package_ndc": "85509-1644-6", "marketing_start_date": "20250729"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85509-1644-9)", "package_ndc": "85509-1644-9", "marketing_start_date": "20250729"}], "brand_name": "Omeprazole", "product_id": "85509-1644_3b19d244-3cd1-0813-e063-6394a90ac153", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "85509-1644", "generic_name": "Omeprazole", "labeler_name": "PHOENIX RX LLC", "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": "20250306", "listing_expiration_date": "20261231"}