NDC 0378-4250

Doxepin Hydrochloride

Doxepin Hydrochloride

Doxepin Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Doxepin Hydrochloride.

Product ID0378-4250_528d1ddf-62f6-451f-a3af-8649e486282c
NDC0378-4250
Product TypeHuman Prescription Drug
Proprietary NameDoxepin Hydrochloride
Generic NameDoxepin Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1986-05-13
Marketing CategoryANDA / ANDA
Application NumberANDA070791
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDOXEPIN HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-4250-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-01)
Marketing Start Date1986-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4250-10 [00378425010]

Doxepin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA070791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-05-13

NDC 0378-4250-01 [00378425001]

Doxepin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA070791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-05-13

Drug Details

Active Ingredients

IngredientStrength
DOXEPIN HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:1533343b-f1ed-4c3a-bb36-23a748452b05
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000048
  • 1000070
  • 1000058
  • 1000097
  • 1000076
  • Pharmacological Class

    • Tricyclic Antidepressant [EPC]
    • Tricyclic Antidepressant [EPC]

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

    NDCBrand NameGeneric Name
    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
    0904-6972Doxepin HydrochlorideDoxepin Hydrochloride
    68071-4464Doxepin HydrochlorideDoxepin Hydrochloride
    68151-5656Doxepin HydrochlorideDoxepin Hydrochloride
    69238-1170Doxepin HydrochlorideDoxepin Hydrochloride
    69238-1166Doxepin HydrochlorideDoxepin Hydrochloride
    69238-1171Doxepin HydrochlorideDoxepin Hydrochloride
    69238-1172Doxepin HydrochlorideDoxepin Hydrochloride
    69238-1173Doxepin HydrochlorideDoxepin Hydrochloride
    70518-0865Doxepin HydrochlorideDoxepin Hydrochloride
    70518-0386Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1555Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1412Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1488Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1734Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1532Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1380Doxepin HydrochlorideDoxepin Hydrochloride
    70518-1525Doxepin HydrochlorideDoxepin Hydrochloride
    71335-0642Doxepin HydrochlorideDoxepin Hydrochloride
    71335-0072Doxepin HydrochlorideDoxepin Hydrochloride
    71335-0780Doxepin HydrochlorideDoxepin Hydrochloride
    21695-441Doxepin HydrochlorideDoxepin Hydrochloride
    21695-943Doxepin HydrochlorideDoxepin Hydrochloride
    35356-424Doxepin HydrochlorideDoxepin Hydrochloride
    35356-650Doxepin HydrochlorideDoxepin Hydrochloride
    40085-716Doxepin HydrochlorideDoxepin Hydrochloride
    42291-247Doxepin HydrochlorideDoxepin Hydrochloride
    43353-329Doxepin HydrochlorideDoxepin Hydrochloride
    43353-331Doxepin HydrochlorideDoxepin Hydrochloride
    45865-775Doxepin HydrochlorideDoxepin Hydrochloride
    45865-849Doxepin HydrochlorideDoxepin Hydrochloride
    49884-220Doxepin HydrochlorideDoxepin Hydrochloride
    49884-219Doxepin HydrochlorideDoxepin Hydrochloride
    49884-218Doxepin HydrochlorideDoxepin Hydrochloride

    © 2023 FDA.report
    This site is not affiliated with or endorsed by the FDA.