omeprazole

Generic: omeprazole

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler northwind health company, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-043
Product ID 82868-043_47a7a66e-084e-6ab3-e063-6394a90a9406
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203270
Listing Expiration 2027-12-31
Marketing Start 2024-01-26

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 82868043
Hyphenated Format 82868-043

Supplemental Identifiers

RxCUI
198051
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
  • 20 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-90)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-96)
source: ndc

Packages (3)

82868-043-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-60) 82868-043-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-90) 82868-043-96 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-96)

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": "47a7a66e-084e-6ab3-e063-6394a90a9406", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["198051"], "spl_set_id": ["10a3fbc9-00c6-ad83-e063-6294a90ae1ad"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-60)", "package_ndc": "82868-043-60", "marketing_start_date": "20250606"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-90)", "package_ndc": "82868-043-90", "marketing_start_date": "20240126"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-043-96)", "package_ndc": "82868-043-96", "marketing_start_date": "20240325"}], "brand_name": "Omeprazole", "product_id": "82868-043_47a7a66e-084e-6ab3-e063-6394a90a9406", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82868-043", "generic_name": "Omeprazole", "labeler_name": "Northwind Health Company, LLC", "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": "20240126", "listing_expiration_date": "20271231"}