omeprazole

Generic: omeprazole

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler aurohealth llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole magnesium 20 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-837
Product ID 58602-837_0c2600f3-e9de-4e73-8ee1-9aeb94d228e4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213201
Listing Expiration 2026-12-31
Marketing Start 2023-04-28

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 58602837
Hyphenated Format 58602-837

Supplemental Identifiers

RxCUI
198051
UPC
0358602837051
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 ANDA213201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

58602-837-05 1 BOTTLE in 1 CARTON (58602-837-05) / 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": "0c2600f3-e9de-4e73-8ee1-9aeb94d228e4", "openfda": {"upc": ["0358602837051"], "unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["19097902-a5e6-423a-8569-31c569cd3cdb"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-837-05)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "58602-837-05", "marketing_start_date": "20230428"}], "brand_name": "Omeprazole", "product_id": "58602-837_0c2600f3-e9de-4e73-8ee1-9aeb94d228e4", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "58602-837", "generic_name": "Omeprazole", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA213201", "marketing_category": "ANDA", "marketing_start_date": "20230428", "listing_expiration_date": "20261231"}