topcare esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler topco associates llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 20 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-627
Product ID 36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207193
Listing Expiration 2026-12-31
Marketing Start 2020-03-12

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 36800627
Hyphenated Format 36800-627

Supplemental Identifiers

RxCUI
606726
UNII
36H71644EQ

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 topcare esomeprazole magnesium (source: ndc)
Generic Name esomeprazole magnesium (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 (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

36800-627-01 1 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 36800-627-03 3 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium dihydrate (20 mg/1)

Linked Drug Pages (1)

topcare esomeprazole magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "61351d9f-87dd-4586-a46a-9ab7fabe41ce", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606726"], "spl_set_id": ["86384845-0bea-490b-b04a-5770ef88b639"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-627-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-627-01", "marketing_start_date": "20200312"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (36800-627-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "36800-627-03", "marketing_start_date": "20200312"}], "brand_name": "topcare esomeprazole magnesium", "product_id": "36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "36800-627", "generic_name": "esomeprazole magnesium", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20200312", "listing_expiration_date": "20261231"}