FDA.reportPublic FDA data

DOXEPIN HYDROCHLORIDE

Product NDC
69315-158
11-digit product format
693150158
Labeler code
69315
Product ID
69315-158_5cc7cb1d-f51f-4a92-8bd2-59c037df9987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXEPIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA211619
Marketing category
ANDA
Marketing start
2021-04-15
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
69315-158-01DOXEPIN HYDROCHLORIDE100 in 1 PACKAGECAPSULE10012
69315-158-10DOXEPIN HYDROCHLORIDE1000 in 1 PACKAGECAPSULE100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-158-01EA - Each69315-1581616aa52-b41b-4ad9-ad2b-2fe8a4cb916712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-158DOXEPIN HYDROCHLORIDE CAPSULE [LEADING PHARMA, LLC]11Current NDC, Legacy NDC, 2 package rows20230421_e6a4cb10-1928-4abe-8797-404c9ddc37dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000058doxepin HCl 100 MG Oral CapsulePSNe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000070doxepin HCl 25 MG Oral CapsulePSNe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000076doxepin HCl 50 MG Oral CapsulePSNe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000097doxepin HCl 75 MG Oral CapsulePSNe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000048doxepin 10 MG Oral CapsuleSCDe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000058doxepin 100 MG Oral CapsuleSCDe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000070doxepin 25 MG Oral CapsuleSCDe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000076doxepin 50 MG Oral CapsuleSCDe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000097doxepin 75 MG Oral CapsuleSCDe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSYe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSYe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYe6a4cb10-1928-4abe-8797-404c9ddc37dd12
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSYe6a4cb10-1928-4abe-8797-404c9ddc37dd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-158-0169315015801100 CAPSULE in 1 PACKAGE (69315-158-01) 100 capsule2021-04-150000-00-00NoNoCurrent
69315-158-10693150158101000 CAPSULE in 1 PACKAGE (69315-158-10) 1000 capsule2021-04-150000-00-00NoNoCurrent