good sense omeprazole delayed release

Generic: omeprazole

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name good sense omeprazole delayed release
Generic Name omeprazole
Labeler l. perrigo company
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-1803
Product ID 0113-1803_bffe358a-cc5a-4ff6-9a04-b0fbca4444e7
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022032
Listing Expiration 2026-12-31
Marketing Start 2021-12-21

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 01131803
Hyphenated Format 0113-1803

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 good sense omeprazole delayed release (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number NDA022032 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (0113-1803-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0113-1803-01)
source: ndc

Packages (1)

0113-1803-03 3 BOTTLE in 1 CARTON (0113-1803-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0113-1803-01)

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

good sense omeprazole delayed release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bffe358a-cc5a-4ff6-9a04-b0fbca4444e7", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["38082e59-c509-4be5-b29c-33a97565df1c"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (0113-1803-03)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0113-1803-01)", "package_ndc": "0113-1803-03", "marketing_start_date": "20211221"}], "brand_name": "good sense omeprazole delayed release", "product_id": "0113-1803_bffe358a-cc5a-4ff6-9a04-b0fbca4444e7", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0113-1803", "generic_name": "omeprazole", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "good sense omeprazole delayed release", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA022032", "marketing_category": "NDA", "marketing_start_date": "20211221", "listing_expiration_date": "20261231"}