omeprazole

Generic: omeprazole

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler aurobindo pharma limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-002
Product ID 59651-002_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a
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 59651002
Hyphenated Format 59651-002

Supplemental Identifiers

RxCUI
198051 199119 200329
UPC
0359651001301 0359651002308 0359651003305
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 ANDA203270 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-01)
  • 3 BLISTER PACK in 1 CARTON (59651-002-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-05)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-30)
  • 10 BLISTER PACK in 1 CARTON (59651-002-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-90)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-99)
source: ndc

Packages (7)

59651-002-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-01) 59651-002-03 3 BLISTER PACK in 1 CARTON (59651-002-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10) 59651-002-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-05) 59651-002-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-30) 59651-002-78 10 BLISTER PACK in 1 CARTON (59651-002-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10) 59651-002-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-90) 59651-002-99 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-99)

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": "4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0359651001301", "0359651002308", "0359651003305"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119", "200329"], "spl_set_id": ["934601b6-fbba-43c4-a8ef-7a7dfe9f9a51"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-01)", "package_ndc": "59651-002-01", "marketing_start_date": "20150819"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59651-002-03)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)", "package_ndc": "59651-002-03", "marketing_start_date": "20150819"}, {"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-05)", "package_ndc": "59651-002-05", "marketing_start_date": "20150819"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-30)", "package_ndc": "59651-002-30", "marketing_start_date": "20150819"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (59651-002-78)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)", "package_ndc": "59651-002-78", "marketing_start_date": "20150819"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-90)", "package_ndc": "59651-002-90", "marketing_start_date": "20150819"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-99)", "package_ndc": "59651-002-99", "marketing_start_date": "20150819"}], "brand_name": "Omeprazole", "product_id": "59651-002_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "59651-002", "generic_name": "Omeprazole", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA203270", "marketing_category": "ANDA", "marketing_start_date": "20150819", "listing_expiration_date": "20261231"}