omeprazole

Generic: omeprazole

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler proficient rx lp
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-061
Product ID 63187-061_0cc267bf-8650-40e3-a05d-e102e275c4c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076048
Marketing Start 2003-11-11
Marketing End 2027-01-31

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 63187061
Hyphenated Format 63187-061

Supplemental Identifiers

RxCUI
198051 199119
UPC
0363187061609 0363187070304
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 ANDA076048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-60)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-72)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-78)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-90)
source: ndc

Packages (5)

63187-061-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-30) 63187-061-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-60) 63187-061-72 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-72) 63187-061-78 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-78) 63187-061-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-90)

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": "0cc267bf-8650-40e3-a05d-e102e275c4c2", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0363187061609", "0363187070304"], "unii": ["KG60484QX9"], "rxcui": ["198051", "199119"], "spl_set_id": ["03ac077f-3873-4087-96d0-89049161dea9"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-30)", "package_ndc": "63187-061-30", "marketing_end_date": "20270131", "marketing_start_date": "20190101"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-60)", "package_ndc": "63187-061-60", "marketing_end_date": "20270131", "marketing_start_date": "20190101"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-72)", "package_ndc": "63187-061-72", "marketing_end_date": "20270131", "marketing_start_date": "20190101"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-78)", "package_ndc": "63187-061-78", "marketing_end_date": "20270131", "marketing_start_date": "20190101"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-90)", "package_ndc": "63187-061-90", "marketing_end_date": "20270131", "marketing_start_date": "20190101"}], "brand_name": "Omeprazole", "product_id": "63187-061_0cc267bf-8650-40e3-a05d-e102e275c4c2", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "63187-061", "generic_name": "Omeprazole", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA076048", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20031111"}