omeprazole 20 mg

Generic: omeprazole 20 mg

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole 20 mg
Generic Name omeprazole 20 mg
Labeler marksans pharma limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-091
Product ID 25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218829
Listing Expiration 2026-12-31
Marketing Start 2025-08-12

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 25000091
Hyphenated Format 25000-091

Supplemental Identifiers

RxCUI
402014
UPC
0325000091767 0325000091774
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 20 mg (source: ndc)
Generic Name omeprazole 20 mg (source: ndc)
Application Number ANDA218829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

25000-091-76 1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 25000-091-77 2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Omeprazole 20 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dcf79426-6aec-432a-aabe-dcb98c0f2cec", "openfda": {"upc": ["0325000091767", "0325000091774"], "unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["921bf750-9dd7-42ff-82bb-043b03f0fe69"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-091-76)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "25000-091-76", "marketing_start_date": "20250812"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-091-77)  / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "25000-091-77", "marketing_start_date": "20250812"}], "brand_name": "Omeprazole 20 mg", "product_id": "25000-091_dcf79426-6aec-432a-aabe-dcb98c0f2cec", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "25000-091", "generic_name": "Omeprazole 20 mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole 20 mg", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA218829", "marketing_category": "ANDA", "marketing_start_date": "20250812", "listing_expiration_date": "20261231"}