Doxepin Hydrochloride

Product NDC
71335-1941
11-digit product format
713351941
Labeler code
71335
Product ID
71335-1941_e5eab47e-ac23-4fed-8ed1-ae046daa85e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213474
Marketing category
ANDA
Marketing start
2021-05-01
Substance
DOXEPIN HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui1000070

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
71335-1941-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE30103
71335-1941-2Doxepin Hydrochloride60 in 1 BOTTLECAPSULE60103
71335-1941-3Doxepin Hydrochloride28 in 1 BOTTLECAPSULE28103
71335-1941-4Doxepin Hydrochloride18 in 1 BOTTLECAPSULE18103
71335-1941-5Doxepin Hydrochloride90 in 1 BOTTLECAPSULE90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1941DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20240524_ec948b3d-4853-41bb-9f01-faf28fe369e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000070doxepin HCl 25 MG Oral CapsulePSNec948b3d-4853-41bb-9f01-faf28fe369e5103
1000070doxepin 25 MG Oral CapsuleSCDec948b3d-4853-41bb-9f01-faf28fe369e5103
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYec948b3d-4853-41bb-9f01-faf28fe369e5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1941-17133519410130 CAPSULE in 1 BOTTLE (71335-1941-1) 30 capsule2021-12-290000-00-00NoNoCurrent
71335-1941-27133519410260 CAPSULE in 1 BOTTLE (71335-1941-2) 60 capsule2021-12-290000-00-00NoNoCurrent
71335-1941-37133519410328 CAPSULE in 1 BOTTLE (71335-1941-3) 28 capsule2021-12-290000-00-00NoNoCurrent
71335-1941-47133519410418 CAPSULE in 1 BOTTLE (71335-1941-4) 18 capsule2021-12-290000-00-00NoNoCurrent
71335-1941-57133519410590 CAPSULE in 1 BOTTLE (71335-1941-5) 90 capsule2021-08-310000-00-00NoNoCurrent