NDC 70518-1912

Delsym

Dextromethorphan

Delsym is a Oral Suspension, Extended Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Dextromethorphan.

Product ID70518-1912_834d9cf8-8368-5768-e053-2991aa0af1a7
NDC70518-1912
Product TypeHuman Otc Drug
Proprietary NameDelsym
Generic NameDextromethorphan
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-03-04
Marketing CategoryNDA / NDA
Application NumberNDA018658
Labeler NameREMEDYREPACK INC.
Substance NameDEXTROMETHORPHAN
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1912-0

1 BOTTLE in 1 CARTON (70518-1912-0) > 89 mL in 1 BOTTLE
Marketing Start Date2019-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1912-0 [70518191200]

Delsym SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA018658
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-04

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

OpenFDA Data

SPL SET ID:fcd03fa7-f7fd-4ddc-aae0-be883f0c7b33
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • 1373128

    • NDC Crossover Matching brand name "Delsym" or generic name "Dextromethorphan"

    NDCBrand NameGeneric Name
    17856-0172DelsymDextromethorphan
    21695-517DelsymDextromethorphan Polistirex
    21695-518DelsymDextromethorphan Polistirex
    50090-0224DelsymDextromethorphan
    63824-110DelsymAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    63824-112Delsymacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    63824-160DelsymDextromethorphan Hydrobromide and Menthol
    63824-161DelsymDEXTROMETHORPHAN HYDROBROMIDE and MENTHOL
    63824-163DelsymDextromethorphan Hydrobromide and Menthol
    63824-164DelsymDextromethorphan Hydrobromide and Menthol
    63824-171DelsymDextromethorphan
    63824-172DelsymDextromethorphan
    63824-175DelsymDextromethorphan
    63824-176DelsymDextromethorphan
    63824-211DelsymAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
    63824-213DelsymDextromethorphan Hydrobromide and Guaifenesin
    63824-215Delsymacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
    63824-221DelsymAcetaminophen and Dextromethorphan Hydrobromide
    70518-1912DelsymDextromethorphan
    17856-0276Delsym (Dextromethorphan)Dextromethorphan
    63824-173Delsym (Dextromethorphan)Dextromethorphan
    63824-177Delsym (Dextromethorphan)Dextromethorphan
    58593-295Mielim y masDextromethorphan
    71598-015RoboTabletsDextromethorphan

    Trademark Results [Delsym]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DELSYM
    DELSYM
    97203302 not registered Live/Pending
    RB Health (US) LLC
    2022-01-05
    DELSYM
    DELSYM
    78545210 not registered Dead/Abandoned
    MAJEDO CORPORATION
    2005-01-11
    DELSYM
    DELSYM
    73404418 1267664 Live/Registered
    Pennwalt Corporation
    1982-12-01
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