FDA.reportPublic FDA data

Doxepin Hydrochloride

Product NDC
62135-560
11-digit product format
621350560
Labeler code
62135
Product ID
62135-560_459bacaf-9b0a-6657-e063-6394a90a66cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210268
Marketing category
ANDA
Marketing start
2020-09-04
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-560-90Doxepin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-560-90EA - Each62135-5604122e169-cec9-4617-9a0e-b42243ffe62112023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-560DOXEPIN HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC]1Current NDC, Legacy NDC, 1 package rows20221206_33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000058doxepin HCl 100 MG Oral CapsulePSN33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000070doxepin HCl 25 MG Oral CapsulePSN33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000076doxepin HCl 50 MG Oral CapsulePSN33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000097doxepin HCl 75 MG Oral CapsulePSN33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000048doxepin 10 MG Oral CapsuleSCD33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000058doxepin 100 MG Oral CapsuleSCD33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000070doxepin 25 MG Oral CapsuleSCD33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000076doxepin 50 MG Oral CapsuleSCD33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000097doxepin 75 MG Oral CapsuleSCD33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000058doxepin (as doxepin HCl) 100 MG Oral CapsuleSY33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000070doxepin (as doxepin HCl) 25 MG Oral CapsuleSY33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32
1000097doxepin (as doxepin HCl) 75 MG Oral CapsuleSY33a15c3f-bec0-4703-a4e9-f8f78f8b5fd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-560-906213505609090 CAPSULE in 1 BOTTLE (62135-560-90) 90 capsule2022-11-220000-00-00YesNoCurrent