omeprazole

Generic: omeprazole

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-963
Product ID 71610-963_43091c83-9815-b7df-e063-6394a90aa05b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212977
Listing Expiration 2026-12-31
Marketing Start 2019-02-20

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 71610963
Hyphenated Format 71610-963

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 ANDA212977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-60)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-70)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-80)
source: ndc

Packages (3)

71610-963-60 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-60) 71610-963-70 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-70) 71610-963-80 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-80)

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": "43091c83-9815-b7df-e063-6394a90aa05b", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["43090803-37de-77e3-e063-6294a90a8c43"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-60)", "package_ndc": "71610-963-60", "marketing_start_date": "20251107"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-70)", "package_ndc": "71610-963-70", "marketing_start_date": "20251107"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-80)", "package_ndc": "71610-963-80", "marketing_start_date": "20251107"}], "brand_name": "Omeprazole", "product_id": "71610-963_43091c83-9815-b7df-e063-6394a90aa05b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71610-963", "generic_name": "Omeprazole", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA212977", "marketing_category": "ANDA", "marketing_start_date": "20190220", "listing_expiration_date": "20261231"}