prilosec

Generic: omeprazole magnesium

Labeler: covis pharma us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prilosec
Generic Name omeprazole magnesium
Labeler covis pharma us, inc
Dosage Form GRANULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 2.5 mg/1

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-625
Product ID 70515-625_296db0e8-af6e-4053-874d-2a7c8f7aba50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022056
Listing Expiration 2026-12-31
Marketing Start 2017-08-25

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 70515625
Hyphenated Format 70515-625

Supplemental Identifiers

RxCUI
797058 797061 797063 797065
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 (source: ndc)
Generic Name omeprazole magnesium (source: ndc)
Application Number NDA022056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)
source: ndc

Packages (1)

70515-625-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)

Ingredients (1)

omeprazole magnesium (2.5 mg/1)

Linked Drug Pages (1)

Prilosec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "296db0e8-af6e-4053-874d-2a7c8f7aba50", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["797058", "797061", "797063", "797065"], "spl_set_id": ["b6761f84-53ac-4745-a8c8-1e5427d7e179"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)", "package_ndc": "70515-625-01", "marketing_start_date": "20170825"}], "brand_name": "Prilosec", "product_id": "70515-625_296db0e8-af6e-4053-874d-2a7c8f7aba50", "dosage_form": "GRANULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70515-625", "generic_name": "omeprazole magnesium", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prilosec", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "2.5 mg/1"}], "application_number": "NDA022056", "marketing_category": "NDA", "marketing_start_date": "20170825", "listing_expiration_date": "20261231"}