FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
42571-423
11-digit product format
425710423
Labeler code
42571
Product ID
42571-423_3a339de3-917e-a3d8-e063-6294a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA217688
Marketing category
ANDA
Marketing start
2024-01-01
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
42571-423-01Doxepin Hydrochloride100 in 1 BOTTLECAPSULE1002
42571-423-13Doxepin Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-423DOXEPIN HYDROCHLORIDE CAPSULE [MICRO LABS LIMITED]1Current NDC, 2 package rows20240101_8a3ba1fd-de34-47e4-96ca-f3086aed4b76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000058doxepin HCl 100 MG Oral CapsulePSN8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000070doxepin HCl 25 MG Oral CapsulePSN8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000076doxepin HCl 50 MG Oral CapsulePSN8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000097doxepin HCl 75 MG Oral CapsulePSN8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000048doxepin 10 MG Oral CapsuleSCD8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000058doxepin 100 MG Oral CapsuleSCD8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000070doxepin 25 MG Oral CapsuleSCD8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000076doxepin 50 MG Oral CapsuleSCD8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000097doxepin 75 MG Oral CapsuleSCD8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY8a3ba1fd-de34-47e4-96ca-f3086aed4b762
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY8a3ba1fd-de34-47e4-96ca-f3086aed4b762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-423-0142571042301100 CAPSULE in 1 BOTTLE (42571-423-01) 100 capsule2024-01-01NoNoCurrent
42571-423-13425710423131000 CAPSULE in 1 BOTTLE (42571-423-13) 1000 capsule2024-01-01NoNoCurrent