Doxepin Hydrochloride

Product NDC
53217-070
11-digit product format
532170070
Labeler code
53217
Product ID
53217-070_9e51fa64-b081-4deb-8f8c-a21836a381d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA070791
Marketing category
ANDA
Marketing start
2012-10-18
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-070-302020-01-31C16284748780-19d75b9cf-f215-f424-e053-dadaa90a57ceDOXEPIN HCL 10MG CAPSULE FOR MYLAN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-070-30Doxepin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-070DOXEPIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_cbdc1f0e-c710-442d-920f-29285cf6991d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNcbdc1f0e-c710-442d-920f-29285cf6991d1
1000048doxepin 10 MG Oral CapsuleSCDcbdc1f0e-c710-442d-920f-29285cf6991d1
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYcbdc1f0e-c710-442d-920f-29285cf6991d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-070-305321700703030 in 1 BOTTLE, PLASTICHistorical