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 CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-755
Product ID 36800-755_b03bf6f6-62bb-458f-ad7d-046defb8bf9b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202538
Listing Expiration 2026-12-31
Marketing Start 2020-08-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800755
Hyphenated Format 36800-755

Supplemental Identifiers

RxCUI
828269
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 ANDA202538 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (36800-755-39) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (36800-755-52) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b03bf6f6-62bb-458f-ad7d-046defb8bf9b", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["828269"], "spl_set_id": ["5cc2e469-9080-4beb-804d-187fc335ccdc"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (36800-755-39)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "36800-755-39", "marketing_start_date": "20200802"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (36800-755-52)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "36800-755-52", "marketing_start_date": "20200802"}], "brand_name": "topcare allergy relief", "product_id": "36800-755_b03bf6f6-62bb-458f-ad7d-046defb8bf9b", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "36800-755", "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": "ANDA202538", "marketing_category": "ANDA", "marketing_start_date": "20200802", "listing_expiration_date": "20261231"}