omeprazole

Generic: omeprazole magnesium

Labeler: up & up
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole magnesium
Labeler up & up
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
UP & UP

Identifiers & Regulatory

Product NDC 11673-948
Product ID 11673-948_ef059a98-451b-4590-93b4-937b855d6595
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210593
Listing Expiration 2026-12-31
Marketing Start 2018-07-21

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 11673948
Hyphenated Format 11673-948

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 ANDA210593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (11673-948-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (11673-948-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

11673-948-14 1 BOTTLE in 1 CARTON (11673-948-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 11673-948-42 3 BOTTLE in 1 CARTON (11673-948-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef059a98-451b-4590-93b4-937b855d6595", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["ac10cf46-1dcc-483a-83d6-2fcb9896cc19"], "manufacturer_name": ["UP & UP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (11673-948-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "11673-948-14", "marketing_start_date": "20180721"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (11673-948-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "11673-948-42", "marketing_start_date": "20180721"}], "brand_name": "Omeprazole", "product_id": "11673-948_ef059a98-451b-4590-93b4-937b855d6595", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "11673-948", "generic_name": "Omeprazole Magnesium", "labeler_name": "UP & UP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA210593", "marketing_category": "ANDA", "marketing_start_date": "20180721", "listing_expiration_date": "20261231"}