omeprazole

Generic: omeprazole magnesium

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole magnesium
Labeler cvs woonsocket prescription center, incorporated
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-271
Product ID 51316-271_6fe0d098-2eb4-49b6-881f-fbe7e102bfcb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216096
Listing Expiration 2026-12-31
Marketing Start 2025-04-01

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 51316271
Hyphenated Format 51316-271

Supplemental Identifiers

RxCUI
198051
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 magnesium (source: ndc)
Application Number ANDA216096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (51316-271-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-271-01)
source: ndc

Packages (1)

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6fe0d098-2eb4-49b6-881f-fbe7e102bfcb", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["8edfcc08-a14e-4579-bd44-045267de5b79"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (51316-271-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-271-01)", "package_ndc": "51316-271-03", "marketing_start_date": "20250401"}], "brand_name": "omeprazole", "product_id": "51316-271_6fe0d098-2eb4-49b6-881f-fbe7e102bfcb", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "51316-271", "generic_name": "Omeprazole magnesium", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA216096", "marketing_category": "ANDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}