topcare childrens allergy

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name topcare childrens allergy
Generic Name loratadine
Labeler topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-608
Product ID 36800-608_3e49bf56-baef-4c33-a38b-a25794c15622
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075728
Listing Expiration 2026-12-31
Marketing Start 2020-07-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800608
Hyphenated Format 36800-608

Supplemental Identifiers

RxCUI
692783
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 childrens allergy (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA075728 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

36800-608-26 1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

topcare childrens allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e49bf56-baef-4c33-a38b-a25794c15622", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["6e175fae-05dd-45c2-b9ab-7d49369a3c05"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-608-26)  / 120 mL in 1 BOTTLE", "package_ndc": "36800-608-26", "marketing_start_date": "20200708"}], "brand_name": "topcare childrens allergy", "product_id": "36800-608_3e49bf56-baef-4c33-a38b-a25794c15622", "dosage_form": "SOLUTION", "product_ndc": "36800-608", "generic_name": "loratadine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare childrens allergy", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA075728", "marketing_category": "ANDA", "marketing_start_date": "20200708", "listing_expiration_date": "20261231"}