topcare 12 hour decongestant

Generic: pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name topcare 12 hour decongestant
Generic Name pseudoephedrine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-054
Product ID 36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Listing Expiration 2026-12-31
Marketing Start 2000-04-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800054
Hyphenated Format 36800-054

Supplemental Identifiers

RxCUI
1049154
UNII
6V9V2RYJ8N

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 12 hour decongestant (source: ndc)
Generic Name pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA075153 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (36800-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (36800-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

36800-054-52 10 BLISTER PACK in 1 CARTON (36800-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 36800-054-60 20 BLISTER PACK in 1 CARTON (36800-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

topcare 12 hour decongestant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["4841c79a-fb92-4209-929a-e4ea0c4015dd"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (36800-054-52)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-054-52", "marketing_start_date": "20000425"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (36800-054-60)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-054-60", "marketing_start_date": "20030520"}], "brand_name": "topcare 12 hour decongestant", "product_id": "36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "36800-054", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare 12 hour decongestant", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_start_date": "20000425", "listing_expiration_date": "20261231"}