NDC 58809-363

Chlorphen SR

Chlorpheniramine Maleate

Chlorphen SR is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Chlorpheniramine Maleate.

Product ID58809-363_e295f573-8eb2-409e-aab7-934107449460
NDC58809-363
Product TypeHuman Otc Drug
Proprietary NameChlorphen SR
Generic NameChlorpheniramine Maleate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA040829
Labeler NameGM Pharmaceuticals, INC
Substance NameCHLORPHENIRAMINE MALEATE
Active Ingredient Strength12 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58809-363-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58809-363-01)
Marketing Start Date2016-01-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-363-01 [58809036301]

Chlorphen SR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040829
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-01-04
Marketing End Date2017-12-28

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE12 mg/1

OpenFDA Data

SPL SET ID:299ca4c9-e458-3ef2-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1363288
    • UPC Code
  • 0358809363018

    • Medicade Reported Pricing

    58809036301 CHLORPHEN SR 12 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Chlorphen SR" or generic name "Chlorpheniramine Maleate"

    NDCBrand NameGeneric Name
    58809-363Chlorphen SRChlorphen SR
    21130-0094 Hour Allergy ReliefChlorpheniramine Maleate
    0536-0370Aller-ChlorChlorpheniramine Maleate
    0536-1006Aller-chlorChlorpheniramine Maleate
    0536-1025Aller-chlorChlorpheniramine Maleate
    0904-0012AllergyChlorpheniramine Maleate
    0363-1941Allergy ReliefChlorpheniramine maleate
    11822-0662allergy reliefChlorpheniramine Maleate
    30142-503Allergy ReliefChlorpheniramine Maleate
    30142-894Allergy ReliefChlorpheniramine maleate
    17714-016Anti AllergyChlorpheniramine Maleate
    10702-017Chlorphen-12Chlorpheniramine Maleate
    15127-821ChlorpheniramineChlorpheniramine Maleate
    0536-3467Chlorpheniramine MaleateChlorpheniramine Maleate
    0485-0098ED CHLORPED JRCHLORPHENIRAMINE MALEATE
    24385-463Good Neighbor Pharmacy AllergyChlorpheniramine Maleate
    0113-0042Good Sense Allergy ReliefChlorpheniramine Maleate
    0113-0404good sense allergy reliefChlorpheniramine Maleate
    0363-0491Wal-FinateChlorpheniramine Maleate
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