topcare allergy and congestion relief

Generic: loratadine, pseudoephedrine sulfate

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

Drug Facts

Product Profile

Brand Name topcare allergy and congestion relief
Generic Name loratadine, pseudoephedrine sulfate
Labeler topco associates llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

loratadine 5 mg/1, pseudoephedrine sulfate 120 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-611
Product ID 36800-611_47f02151-689c-4592-ab13-6c4e259d7a6c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076050
Listing Expiration 2026-12-31
Marketing Start 2018-05-18

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800611
Hyphenated Format 36800-611

Supplemental Identifiers

RxCUI
1242399
UNII
7AJO3BO7QN Y9DL7QPE6B

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 and congestion relief (source: ndc)
Generic Name loratadine, pseudoephedrine sulfate (source: ndc)
Application Number ANDA076050 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (36800-611-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

36800-611-65 30 BLISTER PACK in 1 CARTON (36800-611-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

loratadine (5 mg/1) pseudoephedrine sulfate (120 mg/1)

Linked Drug Pages (1)

topcare allergy and congestion relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f02151-689c-4592-ab13-6c4e259d7a6c", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399"], "spl_set_id": ["dd93d172-2a3a-4e4c-a237-7668acbd537d"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (36800-611-65)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-611-65", "marketing_start_date": "20180518"}], "brand_name": "topcare allergy and congestion relief", "product_id": "36800-611_47f02151-689c-4592-ab13-6c4e259d7a6c", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "36800-611", "generic_name": "loratadine, pseudoephedrine sulfate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare allergy and congestion relief", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "ANDA076050", "marketing_category": "ANDA", "marketing_start_date": "20180518", "listing_expiration_date": "20261231"}