omeprazole

Generic: omeprazole

Labeler: chain drug marketing association, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler chain drug marketing association, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION, INC.

Identifiers & Regulatory

Product NDC 83324-011
Product ID 83324-011_164b1d0f-ad03-40dd-e063-6394a90a6771
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211732
Listing Expiration 2026-12-31
Marketing Start 2024-05-10

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83324011
Hyphenated Format 83324-011

Supplemental Identifiers

RxCUI
402014
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

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 ANDA211732 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (83324-011-14) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER
  • 3 CONTAINER in 1 CARTON (83324-011-42) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER
source: ndc

Packages (2)

83324-011-14 1 CONTAINER in 1 CARTON (83324-011-14) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER 83324-011-42 3 CONTAINER in 1 CARTON (83324-011-42) / 14 TABLET, DELAYED RELEASE in 1 CONTAINER

Ingredients (1)

omeprazole (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": "164b1d0f-ad03-40dd-e063-6394a90a6771", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["da09aac6-8fce-448b-98ba-1fc9bce42075"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (83324-011-14)  / 14 TABLET, DELAYED RELEASE in 1 CONTAINER", "package_ndc": "83324-011-14", "marketing_start_date": "20240510"}, {"sample": false, "description": "3 CONTAINER in 1 CARTON (83324-011-42)  / 14 TABLET, DELAYED RELEASE in 1 CONTAINER", "package_ndc": "83324-011-42", "marketing_start_date": "20240510"}], "brand_name": "Omeprazole", "product_id": "83324-011_164b1d0f-ad03-40dd-e063-6394a90a6771", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "83324-011", "generic_name": "Omeprazole", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA211732", "marketing_category": "ANDA", "marketing_start_date": "20240510", "listing_expiration_date": "20261231"}