topcare allergy relief

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name topcare allergy relief
Generic Name loratadine
Labeler topco associates llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-853
Product ID 36800-853_4bd57bff-c68b-497f-801d-e60d9c7b8390
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076011
Listing Expiration 2026-12-31
Marketing Start 2020-06-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800853
Hyphenated Format 36800-853

Supplemental Identifiers

RxCUI
311373
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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (36800-853-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

36800-853-65 30 BLISTER PACK in 1 CARTON (36800-853-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Topcare Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bd57bff-c68b-497f-801d-e60d9c7b8390", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["32f4e1d1-c830-4752-8251-bcc233bf03f6"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (36800-853-65)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "36800-853-65", "marketing_start_date": "20200625"}], "brand_name": "Topcare Allergy Relief", "product_id": "36800-853_4bd57bff-c68b-497f-801d-e60d9c7b8390", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "36800-853", "generic_name": "loratadine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Allergy Relief", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076011", "marketing_category": "ANDA", "marketing_start_date": "20200625", "listing_expiration_date": "20261231"}