omeprazole

Generic: omeprazole

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 10 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-411
Product ID 68382-411_d0074baa-52cb-4039-9bd8-966a36ff70da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091352
Listing Expiration 2026-12-31
Marketing Start 2012-11-23

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 68382411
Hyphenated Format 68382-411

Supplemental Identifiers

RxCUI
198051 199119 200329
UPC
0368382411013 0368382500014
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 ANDA091352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-01)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-05)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-06)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16)
source: ndc

Packages (5)

68382-411-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-01) 68382-411-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-05) 68382-411-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-06) 68382-411-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-10) 68382-411-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16)

Ingredients (1)

omeprazole (10 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": "d0074baa-52cb-4039-9bd8-966a36ff70da", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0368382411013", "0368382500014"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["9c22ceb2-2c34-43c3-9a35-2589c9078741"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-01)", "package_ndc": "68382-411-01", "marketing_start_date": "20121123"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-05)", "package_ndc": "68382-411-05", "marketing_start_date": "20121123"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-06)", "package_ndc": "68382-411-06", "marketing_start_date": "20121123"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-10)", "package_ndc": "68382-411-10", "marketing_start_date": "20121123"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16)", "package_ndc": "68382-411-16", "marketing_start_date": "20121123"}], "brand_name": "Omeprazole", "product_id": "68382-411_d0074baa-52cb-4039-9bd8-966a36ff70da", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68382-411", "generic_name": "Omeprazole", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA091352", "marketing_category": "ANDA", "marketing_start_date": "20121123", "listing_expiration_date": "20261231"}