NDC 36800-417

Topcare Sinus and Cold D

Naproxen Sodium, Pseudoephedrine Hcl

Topcare Sinus and Cold D is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Naproxen Sodium; Pseudoephedrine Hydrochloride.

Product ID36800-417_4d8cb7a7-523d-46e6-89e9-610fd702e0ff
NDC36800-417
Product TypeHuman Otc Drug
Proprietary NameTopcare Sinus and Cold D
Generic NameNaproxen Sodium, Pseudoephedrine Hcl
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-08-14
Marketing CategoryANDA / ANDA
Application NumberANDA076518
Labeler NameTopco Associates LLC
Substance NameNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength220 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 36800-417-01

20 BLISTER PACK in 1 CARTON (36800-417-01) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2013-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-417-52 [36800041752]

Topcare Sinus and Cold D TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076518
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-14
Marketing End Date2018-03-20

NDC 36800-417-01 [36800041701]

Topcare Sinus and Cold D TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076518
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-14

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN SODIUM220 mg/1

OpenFDA Data

SPL SET ID:55c177ce-1729-4a9b-a5ae-2b6c96fbc27a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1367426
    • UPC Code
  • 0036800375727

    • NDC Crossover Matching brand name "Topcare Sinus and Cold D" or generic name "Naproxen Sodium, Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    36800-417Topcare Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    0363-0650All Day Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    46122-197Good Neighbor Pharmacy Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    62011-0204Health Mart Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    70000-0605Leader All Day Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    70000-0281Leader Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    0113-2417sinus and cold dNaproxen sodium, Pseudoephedrine HCl
    41250-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    59779-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    49348-393Sunmark Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
    11673-417Up and Up Sinus and Cold DNaproxen sodium, Pseudoephedrine HCl
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