acid reducer

Generic: omeprazole

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acid reducer
Generic Name omeprazole
Labeler rugby laboratories
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1322
Product ID 0536-1322_6616864c-9739-4e69-86a1-29c07441f9ba
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206877
Listing Expiration 2027-12-31
Marketing Start 2020-09-15

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 05361322
Hyphenated Format 0536-1322

Supplemental Identifiers

RxCUI
402014
UPC
0305361322885
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 (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0536-1322-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

0536-1322-13 3 BOTTLE in 1 CARTON (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 0536-1322-71 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 0536-1322-88 1 BOTTLE in 1 CARTON (0536-1322-88) / 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": "6616864c-9739-4e69-86a1-29c07441f9ba", "openfda": {"upc": ["0305361322885"], "unii": ["426QFE7XLK"], "rxcui": ["402014"], "spl_set_id": ["33990795-e994-4307-a570-9e8e8b44c473"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (0536-1322-13)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0536-1322-13", "marketing_start_date": "20200915"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0536-1322-71)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0536-1322-71", "marketing_start_date": "20200915"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0536-1322-88)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0536-1322-88", "marketing_start_date": "20200915"}], "brand_name": "Acid Reducer", "product_id": "0536-1322_6616864c-9739-4e69-86a1-29c07441f9ba", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0536-1322", "generic_name": "Omeprazole", "labeler_name": "Rugby Laboratories", "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": "20200915", "listing_expiration_date": "20271231"}