omeprazole

Generic: omeprazole

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler p & l development, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 59726-744
Product ID 59726-744_d8e96cde-13b1-4f97-8e0d-4a60f28e270e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206582
Listing Expiration 2026-12-31
Marketing Start 2025-08-29

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59726744
Hyphenated Format 59726-744

Supplemental Identifiers

RxCUI
402014
UNII
426QFE7XLK

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 ANDA206582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE, PLASTIC in 1 BOX (59726-744-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

59726-744-42 3 BOTTLE, PLASTIC in 1 BOX (59726-744-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Ingredients (1)

omeprazole magnesium (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": "d8e96cde-13b1-4f97-8e0d-4a60f28e270e", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["883e428a-e157-4bbf-8657-e7a93dc99e8c"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (59726-744-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC", "package_ndc": "59726-744-42", "marketing_start_date": "20250829"}], "brand_name": "Omeprazole", "product_id": "59726-744_d8e96cde-13b1-4f97-8e0d-4a60f28e270e", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "59726-744", "generic_name": "Omeprazole", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA206582", "marketing_category": "ANDA", "marketing_start_date": "20250829", "listing_expiration_date": "20261231"}