topcare allergy relief 24 hour

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name topcare allergy relief 24 hour
Generic Name loratadine
Labeler topco associates llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-612
Product ID 36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2005-01-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800612
Hyphenated Format 36800-612

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

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 allergy relief 24 hour (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (5)

36800-612-03 1 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLE 36800-612-46 10 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACK 36800-612-58 1 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLE 36800-612-65 1 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLE 36800-612-87 1 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

TopCare Allergy Relief 24 hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9fd9c4c8-9520-470a-9deb-e050233a6e92", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["a500aebf-a020-4da9-afdb-a699077cb8e1"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-612-03)  / 70 TABLET in 1 BOTTLE", "package_ndc": "36800-612-03", "marketing_start_date": "20140305"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (36800-612-46)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "36800-612-46", "marketing_start_date": "20050128"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-612-58)  / 40 TABLET in 1 BOTTLE", "package_ndc": "36800-612-58", "marketing_start_date": "20140219"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-612-65)  / 30 TABLET in 1 BOTTLE", "package_ndc": "36800-612-65", "marketing_start_date": "20050125"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-612-87)  / 300 TABLET in 1 BOTTLE", "package_ndc": "36800-612-87", "marketing_start_date": "20091218"}], "brand_name": "TopCare Allergy Relief 24 hour", "product_id": "36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92", "dosage_form": "TABLET", "product_ndc": "36800-612", "generic_name": "Loratadine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Allergy Relief", "brand_name_suffix": "24 hour", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20050125", "listing_expiration_date": "20261231"}