prilosec otc

Generic: omeprazole magnesium

Labeler: the procter & gamble manufacturing company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prilosec otc
Generic Name omeprazole magnesium
Labeler the procter & gamble manufacturing company
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20.6 mg/1

Manufacturer
The Procter & Gamble Manufacturing Company

Identifiers & Regulatory

Product NDC 84126-300
Product ID 84126-300_372926c4-480a-ac1e-e063-6394a90a5293
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206582
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

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 84126300
Hyphenated Format 84126-300

Supplemental Identifiers

RxCUI
402014 608796
UPC
0030772202883
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 prilosec otc (source: ndc)
Generic Name omeprazole magnesium (source: ndc)
Application Number ANDA206582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20.6 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (84126-300-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (84126-300-24) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (84126-300-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

84126-300-14 1 BLISTER PACK in 1 CARTON (84126-300-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 84126-300-24 2 BLISTER PACK in 1 CARTON (84126-300-24) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 84126-300-42 3 BLISTER PACK in 1 CARTON (84126-300-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole magnesium (20.6 mg/1)

Linked Drug Pages (1)

Prilosec OTC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "372926c4-480a-ac1e-e063-6394a90a5293", "openfda": {"upc": ["0030772202883"], "unii": ["426QFE7XLK"], "rxcui": ["402014", "608796"], "spl_set_id": ["37291cab-e350-d8e3-e063-6294a90a9cb1"], "manufacturer_name": ["The Procter & Gamble Manufacturing Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (84126-300-14)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "84126-300-14", "marketing_start_date": "20250901"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (84126-300-24)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "84126-300-24", "marketing_start_date": "20250901"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (84126-300-42)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "84126-300-42", "marketing_start_date": "20250901"}], "brand_name": "Prilosec OTC", "product_id": "84126-300_372926c4-480a-ac1e-e063-6394a90a5293", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "84126-300", "generic_name": "OMEPRAZOLE MAGNESIUM", "labeler_name": "The Procter & Gamble Manufacturing Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Prilosec OTC", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20.6 mg/1"}], "application_number": "ANDA206582", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}