good sense omeprazole

Generic: omeprazole

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

Drug Facts

Product Profile

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

omeprazole 20 mg/1

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-0520
Product ID 0113-0520_5e2cb7f9-93ec-4919-9648-0ecb1c5fe086
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA209400
Listing Expiration 2026-12-31
Marketing Start 2018-06-19

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 01130520
Hyphenated Format 0113-0520

Supplemental Identifiers

RxCUI
2003656
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 (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number NDA209400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 CARTON in 1 CARTON (0113-0520-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 14 BLISTER PACK in 1 CARTON (0113-0520-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0113-0520-55 3 CARTON in 1 CARTON (0113-0520-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 0113-0520-74 14 BLISTER PACK in 1 CARTON (0113-0520-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

good sense omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e2cb7f9-93ec-4919-9648-0ecb1c5fe086", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["2003656"], "spl_set_id": ["dcd93796-8904-415d-a379-c4ea590cf544"], "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 CARTON in 1 CARTON (0113-0520-55)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0113-0520-55", "marketing_start_date": "20180621"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (0113-0520-74)  / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0113-0520-74", "marketing_start_date": "20180619"}], "brand_name": "good sense omeprazole", "product_id": "0113-0520_5e2cb7f9-93ec-4919-9648-0ecb1c5fe086", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0113-0520", "generic_name": "omeprazole", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "good sense omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA209400", "marketing_category": "NDA", "marketing_start_date": "20180619", "listing_expiration_date": "20261231"}