NDC 50268-317

Fexofenadine hydrochloride

Fexofenadine Hydrochloride

Fexofenadine hydrochloride is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Avpak. The primary component is Fexofenadine Hydrochloride.

Product ID50268-317_80c5e635-a8dc-04ad-e053-2991aa0a3e34
NDC50268-317
Product TypeHuman Otc Drug
Proprietary NameFexofenadine hydrochloride
Generic NameFexofenadine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA202039
Labeler NameAvPAK
Substance NameFEXOFENADINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50268-317-13

30 BLISTER PACK in 1 BOX (50268-317-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-317-11)
Marketing Start Date2019-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-317-13 [50268031713]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-28
Marketing End Date2020-02-03

NDC 50268-317-11 [50268031711]

Fexofenadine hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202039
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-28
Marketing End Date2020-02-03

Drug Details

Active Ingredients

IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:80c5e635-a8db-04ad-e053-2991aa0a3e34
Manufacturer
UNII

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
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