prilosec otc

Generic: omeprazole magnesium

Labeler: the procter & gamble manufacturing company
NDC Directory HUMAN OTC DRUG NDA 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 37000-455
Product ID 37000-455_401e1256-05e3-d4a9-e063-6294a90adce4
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021229
Listing Expiration 2026-12-31
Marketing Start 2003-07-14

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 37000455
Hyphenated Format 37000-455

Supplemental Identifiers

RxCUI
402014 608796
UPC
0037000359067
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 NDA021229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20.6 mg/1
source: ndc
Packaging
  • 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01)
  • 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 2 CARTON in 1 CARTON (37000-455-03) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 CARTON (37000-455-04) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05)
source: ndc

Packages (5)

37000-455-01 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01) 37000-455-02 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 37000-455-03 2 CARTON in 1 CARTON (37000-455-03) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 37000-455-04 3 CARTON in 1 CARTON (37000-455-04) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK 37000-455-05 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05)

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": "401e1256-05e3-d4a9-e063-6294a90adce4", "openfda": {"upc": ["0037000359067"], "unii": ["426QFE7XLK"], "rxcui": ["402014", "608796"], "spl_set_id": ["77ed80a2-a482-4838-ac55-4865b5c31d9f"], "manufacturer_name": ["The Procter & Gamble Manufacturing Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01)", "package_ndc": "37000-455-01", "marketing_start_date": "20030714"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (37000-455-02)  / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "37000-455-02", "marketing_start_date": "20030714"}, {"sample": false, "description": "2 CARTON in 1 CARTON (37000-455-03)  / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "37000-455-03", "marketing_start_date": "20030714"}, {"sample": false, "description": "3 CARTON in 1 CARTON (37000-455-04)  / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "37000-455-04", "marketing_start_date": "20030714"}, {"sample": false, "description": "1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05)", "package_ndc": "37000-455-05", "marketing_start_date": "20030714"}], "brand_name": "Prilosec OTC", "product_id": "37000-455_401e1256-05e3-d4a9-e063-6294a90adce4", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "37000-455", "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": "NDA021229", "marketing_category": "NDA", "marketing_start_date": "20030714", "listing_expiration_date": "20261231"}