NDC 0904-5961

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Fexofenadine Hydrochloride.

Product ID0904-5961_42579609-eccc-473c-8dd9-a94b94a74832
NDC0904-5961
Product TypeHuman Prescription Drug
Proprietary NameFexofenadine Hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA076502
Labeler NameMajor Pharmaceuticals
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0904-5961-61

100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-5961-61)
Marketing Start Date2009-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5961-61 [00904596161]

Fexofenadine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076502
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-10
Marketing End Date2013-12-16

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:107ea1b7-5fbd-46a3-bc42-da620674f350
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997488
  • 997420
  • 997501
  • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Fexofenadine Hydrochloride" or generic name "Fexofenadine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0095Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0097Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-0783Fexofenadine hydrochlorideFexofenadine hydrochloride
    0363-9898Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0378-0781Fexofenadine Hydrochloridefexofenadine
    0378-0782Fexofenadine Hydrochloridefexofenadine
    0615-5619Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-5620Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7636Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0615-7696Fexofenadine HydrochlorideFexofenadine
    0904-5961Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5962Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-5963Fexofenadine HydrochlorideFexofenadine Hydrochloride
    0904-6214fexofenadine hydrochloridefexofenadine hydrochloride
    0904-6711Fexofenadine hydrochlorideFexofenadine hydrochloride
    0904-6979Fexofenadine HydrochlorideFexofenadine HCl
    0904-7050Fexofenadine HydrochlorideFexofenadine HCl
    10202-229Fexofenadine hydrochlorideFexofenadine hydrochloride
    10544-231Fexofenadine HydrochlorideFexofenadine HCl
    68071-2176fexofenadine hydrochloridefexofenadine hydrochloride
    68016-995Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68071-1896Fexofenadine hydrochlorideFexofenadine hydrochloride
    68071-3228Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68151-1452Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68151-3977fexofenadine hydrochloridefexofenadine hydrochloride
    68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE
    68196-976Fexofenadine hydrochlorideFexofenadine hydrochloride
    68554-5061Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68554-5063Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68554-5062Fexofenadine HydrochlorideFexofenadine Hydrochloride
    68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloride
    68788-6776fexofenadine hydrochloridefexofenadine hydrochloride
    69842-052Fexofenadine HydrochlorideFexofenadine Hydrochloride
    69848-002Fexofenadine HydrochlorideFexofenadine Hydrochloride
    70518-0746Fexofenadine HydrochlorideFexofenadine Hydrochloride
    70518-1218Fexofenadine hydrochlorideFexofenadine hydrochloride
    70518-1702fexofenadine hydrochloridefexofenadine hydrochloride
    70677-0008Fexofenadine hydrochlorideFexofenadine hydrochloride
    70677-0007Fexofenadine hydrochlorideFexofenadine hydrochloride
    71335-0290Fexofenadine HydrochlorideFexofenadine Hydrochloride
    71335-0721fexofenadine hydrochloridefexofenadine hydrochloride
    71335-0483Fexofenadine hydrochlorideFexofenadine hydrochloride
    71610-041fexofenadine hydrochloridefexofenadine hydrochloride
    13107-066Fexofenadine hydrochlorideFexofenadine hydrochloride
    13107-067Fexofenadine hydrochlorideFexofenadine hydrochloride
    21695-461Fexofenadine HydrochlorideFexofenadine Hydrochloride
    21695-462Fexofenadine HydrochlorideFexofenadine Hydrochloride
    30142-878Fexofenadine hydrochlorideFexofenadine hydrochloride
    33261-228fexofenadine hydrochloridefexofenadine hydrochloride
    35356-749fexofenadine hydrochloridefexofenadine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.