FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
23155-797
11-digit product format
231550797
Labeler code
23155
Product ID
23155-797_b170c5a1-48e2-4532-8324-cce5229fe09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA214908
Marketing category
ANDA
Marketing start
2021-12-30
Substance
DOXEPIN HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXEPIN HYDROCHLORIDE
Listing expiration
2027-12-31

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
23155-797-01DOXEPIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-797-01EA - Each23155-797ffa040e1-10fc-43e7-a3bb-945bc75f52c212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-797DOXEPIN HYDROCHLORIDE CAPSULE DOXEPIN HYDROCHLORIDE (DOXEPN HYDROCHLORIDE) CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 1 package rows20211230_89ed6385-cf6a-458e-81ea-c7f3fead41c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000058doxepin HCl 100 MG Oral CapsulePSN89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000070doxepin HCl 25 MG Oral CapsulePSN89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000076doxepin HCl 50 MG Oral CapsulePSN89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000097doxepin HCl 75 MG Oral CapsulePSN89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000048doxepin 10 MG Oral CapsuleSCD89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000058doxepin 100 MG Oral CapsuleSCD89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000070doxepin 25 MG Oral CapsuleSCD89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000076doxepin 50 MG Oral CapsuleSCD89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000097doxepin 75 MG Oral CapsuleSCD89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY89ed6385-cf6a-458e-81ea-c7f3fead41c52
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY89ed6385-cf6a-458e-81ea-c7f3fead41c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-797-0123155079701100 CAPSULE in 1 BOTTLE (23155-797-01) 100 capsule2021-12-300000-00-00NoNoCurrent