Doxepin Hydrochloride

Product NDC
21695-441
11-digit product format
216950441
Labeler code
21695
Product ID
21695-441_f6ffd0d8-3451-425e-921e-faae1c1b8ad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070789
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-441-302019-09-24C16284748780-1934fe258-4a79-48b1-e053-8cdaa90a720aDOXEPIN HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-441-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-441DOXEPIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 1 package rows20110517_24dd378e-0ef9-4ef8-8032-f81c1d87b3b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSN24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin HCl 50 MG Oral CapsulePSN24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000048doxepin 10 MG Oral CapsuleSCD24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin 50 MG Oral CapsuleSCD24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSY24dd378e-0ef9-4ef8-8032-f81c1d87b3b82
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSY24dd378e-0ef9-4ef8-8032-f81c1d87b3b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-441-302169504413030 in 1 BOTTLE, PLASTICHistorical