omeprazole

Generic: omeprazole

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler innovus pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20.6 mg/1

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-740
Product ID 57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210593
Listing Expiration 2026-12-31
Marketing Start 2020-08-06

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 57483740
Hyphenated Format 57483-740

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 (source: ndc)
Application Number ANDA210593 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20.6 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01)
source: ndc

Packages (1)

57483-740-42 3 BOTTLE in 1 CARTON (57483-740-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01)

Ingredients (1)

omeprazole magnesium (20.6 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": "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["ce5c9fdc-0c50-4315-8f11-e00c9810abd0"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (57483-740-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57483-740-01)", "package_ndc": "57483-740-42", "marketing_start_date": "20200806"}], "brand_name": "omeprazole", "product_id": "57483-740_ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57483-740", "generic_name": "omeprazole", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20.6 mg/1"}], "application_number": "ANDA210593", "marketing_category": "ANDA", "marketing_start_date": "20200806", "listing_expiration_date": "20261231"}