NDC 64380-203

Doxepin

Doxepin Hydrochloride

Doxepin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Doxepin Hydrochloride.

Product ID64380-203_31004076-5189-4800-bdc7-e43aadcbd96c
NDC64380-203
Product TypeHuman Prescription Drug
Proprietary NameDoxepin
Generic NameDoxepin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-09-12
Marketing CategoryANDA /
Application NumberANDA202510
Labeler NameStrides Pharma Science Limited
Substance NameDOXEPIN HYDROCHLORIDE
Active Ingredient Strength3 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64380-203-01

30 TABLET in 1 BOTTLE, PLASTIC (64380-203-01)
Marketing Start Date2022-09-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0228-3315DoxepinDoxepin
0228-3316DoxepinDoxepin
0378-1049Doxepin Hydrochloridedoxepin hydrochloride
0378-3125Doxepin Hydrochloridedoxepin hydrochloride
0378-4250Doxepin Hydrochloridedoxepin hydrochloride
0378-4810Doxepin HydrochlorideDoxepin Hydrochloride
0378-4811Doxepin HydrochlorideDoxepin Hydrochloride
0378-5375Doxepin Hydrochloridedoxepin hydrochloride
0378-5390Doxepin Hydrochloridedoxepin hydrochloride
0378-5391Doxepin Hydrochloridedoxepin hydrochloride
0378-6410Doxepin Hydrochloridedoxepin hydrochloride
0378-8117Doxepin HydrochlorideDoxepin Hydrochloride
0527-4062Doxepin HydrochlorideDoxepin Hydrochloride
0527-4063Doxepin HydrochlorideDoxepin Hydrochloride
0527-4064Doxepin HydrochlorideDoxepin Hydrochloride
0527-4065Doxepin HydrochlorideDoxepin Hydrochloride
0527-4066Doxepin HydrochlorideDoxepin Hydrochloride
0904-6970Doxepin HydrochlorideDoxepin Hydrochloride
0904-6971Doxepin HydrochlorideDoxepin Hydrochloride
0378-8130PRUDOXINdoxepin hydrochloride
0378-8123Zonalondoxepin hydrochloride

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