careone esomeprazole magnesium

Generic: esomeprazole

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone esomeprazole magnesium
Generic Name esomeprazole
Labeler american sales company
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole 20 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-727
Product ID 41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207193
Listing Expiration 2026-12-31
Marketing Start 2017-09-26

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 41520727
Hyphenated Format 41520-727

Supplemental Identifiers

RxCUI
606726
UNII
N3PA6559FT
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 careone esomeprazole magnesium (source: ndc)
Generic Name esomeprazole (source: ndc)
Application Number ANDA207193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

41520-727-01 1 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 41520-727-03 3 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole (20 mg/1)

Linked Drug Pages (1)

careone esomeprazole magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "96c2b7f1-ae2c-4b41-b58a-183b654a70ff", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["606726"], "spl_set_id": ["3f9a2747-8afd-4898-bbfb-5f379293137e"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-727-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "41520-727-01", "marketing_start_date": "20171013"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (41520-727-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "41520-727-03", "marketing_start_date": "20170926"}], "brand_name": "careone esomeprazole magnesium", "product_id": "41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "41520-727", "generic_name": "Esomeprazole", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "careone esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20170926", "listing_expiration_date": "20261231"}