FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
0378-5375
11-digit product format
003785375
Labeler code
0378
Product ID
0378-5375_335104fb-31eb-4460-b3ab-19869176b320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
0378-5375-01Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10018
0378-5375-10Doxepin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE100018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5375DOXEPIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20240920_1533343b-f1ed-4c3a-bb36-23a748452b05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin HCl 100 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin HCl 25 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin HCl 50 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin HCl 75 MG Oral CapsulePSN1533343b-f1ed-4c3a-bb36-23a748452b0518
1000048doxepin 10 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin 100 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin 25 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin 50 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin 75 MG Oral CapsuleSCD1533343b-f1ed-4c3a-bb36-23a748452b0518
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY1533343b-f1ed-4c3a-bb36-23a748452b0518
1000097doxepin HCl 75 MG Oral CapsulePSN718b6ebd-279e-4de0-ad46-c1d2a25ed19d2
1000097doxepin 75 MG Oral CapsuleSCD718b6ebd-279e-4de0-ad46-c1d2a25ed19d2
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY718b6ebd-279e-4de0-ad46-c1d2a25ed19d2
1000058doxepin HCl 100 MG Oral CapsulePSN1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000076doxepin HCl 50 MG Oral CapsulePSN1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000097doxepin HCl 75 MG Oral CapsulePSN1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000058doxepin 100 MG Oral CapsuleSCD1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000076doxepin 50 MG Oral CapsuleSCD1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000097doxepin 75 MG Oral CapsuleSCD1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY1edc1fca-9ac7-4adf-b894-bf8ca392ce4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5375-0100378537501100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-01) 100 capsule1986-05-130000-00-00NoNoCurrent
0378-5375-10003785375101000 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-10) 1000 capsule1986-05-130000-00-00NoNoCurrent