omeprazole

Generic: omeprazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler a-s medication solutions
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 40 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7366
Product ID 50090-7366_95ba60a4-3fe5-4236-b928-e774453ae8e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203270
Listing Expiration 2026-12-31
Marketing Start 2015-08-19

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 500907366
Hyphenated Format 50090-7366

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 ANDA203270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-0)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-1)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-2)
  • 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-3)
source: ndc

Packages (4)

50090-7366-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-0) 50090-7366-1 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-1) 50090-7366-2 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-2) 50090-7366-3 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-3)

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": "95ba60a4-3fe5-4236-b928-e774453ae8e0", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["200329"], "spl_set_id": ["c1276463-7357-45b5-9f7e-8d3c4a550ff4"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-0)", "package_ndc": "50090-7366-0", "marketing_start_date": "20241018"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-1)", "package_ndc": "50090-7366-1", "marketing_start_date": "20241018"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-2)", "package_ndc": "50090-7366-2", "marketing_start_date": "20241018"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7366-3)", "package_ndc": "50090-7366-3", "marketing_start_date": "20241018"}], "brand_name": "Omeprazole", "product_id": "50090-7366_95ba60a4-3fe5-4236-b928-e774453ae8e0", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "50090-7366", "generic_name": "Omeprazole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}], "application_number": "ANDA203270", "marketing_category": "ANDA", "marketing_start_date": "20150819", "listing_expiration_date": "20261231"}