FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
59651-175
11-digit product format
596510175
Labeler code
59651
Product ID
59651-175_5b5efe70-cce2-4950-94f0-d3aa869e442e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA211603
Marketing category
ANDA
Marketing start
2019-03-27
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000048, 1000058, 1000070, 1000076, 1000097

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6fcd62d-384f-5faa-05d7-c5d5903c6c43Product name420250515
3d5463a5-d368-9c2b-b40c-0f2b688e406eProduct name920240805
750bc85a-c69c-4145-a865-3f1124677d16Product name320240321
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-175-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-175-01EA - Each59651-175954bfdb4-4835-427d-b9b4-52d655e6d7d112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-175DOXEPIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20241011_f3c242dd-426e-4c69-8f21-2645361d5f27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin HCl 100 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin HCl 25 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin HCl 50 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin HCl 75 MG Oral CapsulePSNf3c242dd-426e-4c69-8f21-2645361d5f275
1000048doxepin 10 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin 100 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin 25 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin 50 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin 75 MG Oral CapsuleSCDf3c242dd-426e-4c69-8f21-2645361d5f275
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYf3c242dd-426e-4c69-8f21-2645361d5f275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-175-0159651017501100 CAPSULE in 1 BOTTLE (59651-175-01) 100 capsule2019-03-270000-00-00NoNoCurrent