FDA.reportPublic FDA data

Doxepin hydrochloride

Product NDC
71335-9732
11-digit product format
713359732
Labeler code
71335
Product ID
71335-9732_cfc63853-77b0-4c21-981e-ddea13fcc09c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212624
Marketing category
ANDA
Marketing start
2019-12-20
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
Rxcui1000076

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
71335-9732-1Doxepin hydrochloride60 in 1 BOTTLECAPSULE60100
71335-9732-2Doxepin hydrochloride30 in 1 BOTTLECAPSULE30100
71335-9732-3Doxepin hydrochloride90 in 1 BOTTLECAPSULE90100
71335-9732-4Doxepin hydrochloride120 in 1 BOTTLECAPSULE120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9732DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20230701_41046d94-1443-4bbd-96d0-8463604ae459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000076doxepin HCl 50 MG Oral CapsulePSN41046d94-1443-4bbd-96d0-8463604ae459100
1000076doxepin 50 MG Oral CapsuleSCD41046d94-1443-4bbd-96d0-8463604ae459100
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY41046d94-1443-4bbd-96d0-8463604ae459100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9732-17133597320160 CAPSULE in 1 BOTTLE (71335-9732-1) 60 capsule2023-06-30NoNoHistorical
71335-9732-27133597320230 CAPSULE in 1 BOTTLE (71335-9732-2) 30 capsule2023-06-30NoNoHistorical
71335-9732-37133597320390 CAPSULE in 1 BOTTLE (71335-9732-3) 90 capsule2023-06-30NoNoHistorical
71335-9732-471335973204120 CAPSULE in 1 BOTTLE (71335-9732-4) 120 capsule2023-06-30NoNoHistorical