FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
71335-2472
11-digit product format
713352472
Labeler code
71335
Product ID
71335-2472_63f9452b-c437-482e-86e5-17f5a99b9a2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215076
Marketing category
ANDA
Marketing start
2021-04-23
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
71335-2472-1DOXEPIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE60100
71335-2472-2DOXEPIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE30100
71335-2472-3DOXEPIN HYDROCHLORIDE90 in 1 BOTTLECAPSULE90100
71335-2472-4DOXEPIN HYDROCHLORIDE120 in 1 BOTTLECAPSULE120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2472DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20241115_19c8ad61-4e4f-4c59-b196-34a4e470459f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000076doxepin HCl 50 MG Oral CapsulePSN19c8ad61-4e4f-4c59-b196-34a4e470459f100
1000076doxepin 50 MG Oral CapsuleSCD19c8ad61-4e4f-4c59-b196-34a4e470459f100
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY19c8ad61-4e4f-4c59-b196-34a4e470459f100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2472-17133524720160 CAPSULE in 1 BOTTLE (71335-2472-1) 60 capsule2024-11-13NoNoHistorical
71335-2472-27133524720230 CAPSULE in 1 BOTTLE (71335-2472-2) 30 capsule2024-11-13NoNoHistorical
71335-2472-37133524720390 CAPSULE in 1 BOTTLE (71335-2472-3) 90 capsule2024-11-13NoNoHistorical
71335-2472-471335247204120 CAPSULE in 1 BOTTLE (71335-2472-4) 120 capsule2024-11-13NoNoHistorical