acid reducer

Generic: omeprazole

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

Drug Facts

Product Profile

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

omeprazole magnesium 20 mg/1

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-120
Product ID 57483-120_a8fbf112-5de0-42fc-801f-6f21a09b1976
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206877
Listing Expiration 2026-12-31
Marketing Start 2023-05-25

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 57483120
Hyphenated Format 57483-120

Supplemental Identifiers

RxCUI
402014
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 acid reducer (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA206877 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (57483-120-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

57483-120-42 3 BOTTLE in 1 CARTON (57483-120-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Acid Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8fbf112-5de0-42fc-801f-6f21a09b1976", "openfda": {"unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["a4e92bd2-8f75-4acc-9b75-df8332bd4cc4"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (57483-120-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "57483-120-42", "marketing_start_date": "20230525"}], "brand_name": "Acid Reducer", "product_id": "57483-120_a8fbf112-5de0-42fc-801f-6f21a09b1976", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57483-120", "generic_name": "Omeprazole", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acid Reducer", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA206877", "marketing_category": "ANDA", "marketing_start_date": "20230525", "listing_expiration_date": "20261231"}