NDC 43353-331

Doxepin Hydrochloride

Doxepin Hydrochloride

Doxepin Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Doxepin Hydrochloride.

Product ID43353-331_a3797445-680f-449e-8ffd-522445906bdb
NDC43353-331
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 NameAphena Pharma Solutions - Tennessee, LLC
Substance NameDOXEPIN HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-331-09

9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-09)
Marketing Start Date2017-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-331-09 [43353033109]

Doxepin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA070791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-21

NDC 43353-331-16 [43353033116]

Doxepin Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA070791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-25

Drug Details

Active Ingredients

IngredientStrength
DOXEPIN HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:10d9eba6-30d1-448a-8d92-a1a02df03303
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000048
  • 1000070
  • 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

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