FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
0378-6410
11-digit product format
003786410
Labeler code
0378
Product ID
0378-6410_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
100 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 HYDROCHLORIDE100 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
0378-6410-01Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10018
0378-6410-10Doxepin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE100018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6410DOXEPIN 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
1000048doxepin HCl 10 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin HCl 100 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin HCl 25 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin HCl 50 MG Oral CapsulePSN137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin 10 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin 100 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin 25 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin 50 MG Oral CapsuleSCD137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY137a953b-3c48-405f-86a6-ff778cb7f5f212
1000048doxepin HCl 10 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin HCl 10 MG Oral CapsulePSN4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000058doxepin HCl 100 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin HCl 100 MG Oral CapsulePSN4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000070doxepin HCl 25 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin HCl 50 MG Oral CapsulePSNa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin HCl 50 MG Oral CapsulePSN4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000048doxepin 10 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin 10 MG Oral CapsuleSCD4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000058doxepin 100 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin 100 MG Oral CapsuleSCD4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000070doxepin 25 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin 50 MG Oral CapsuleSCD4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000076doxepin 50 MG Oral CapsuleSCDa2297f75-c498-419b-aa29-057271313a7f2
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY4e9b122b-eddf-42d3-aeae-bee38badb2d52
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYa2297f75-c498-419b-aa29-057271313a7f2
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
0378-6410-0100378641001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-01) 100 capsule1986-05-130000-00-00NoNoCurrent
0378-6410-10003786410101000 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-10) 1000 capsule1986-05-130000-00-00NoNoCurrent