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 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-829
Product ID 43353-829_1b00384a-efea-458c-8485-5da3db9d28d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075410
Listing Expiration 2026-12-31
Marketing Start 2009-01-23

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 43353829
Hyphenated Format 43353-829

Supplemental Identifiers

RxCUI
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 ANDA075410 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)
source: ndc

Packages (2)

43353-829-60 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60) 43353-829-80 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)

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": "1b00384a-efea-458c-8485-5da3db9d28d6", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["4b188d97-f1b3-468d-9818-b8333bf24b5a"], "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, PLASTIC (43353-829-60)", "package_ndc": "43353-829-60", "marketing_start_date": "20130325"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)", "package_ndc": "43353-829-80", "marketing_start_date": "20201111"}], "brand_name": "Omeprazole", "product_id": "43353-829_1b00384a-efea-458c-8485-5da3db9d28d6", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "43353-829", "generic_name": "omeprazole", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA075410", "marketing_category": "ANDA", "marketing_start_date": "20090123", "listing_expiration_date": "20261231"}