Doxepin Hydrochloride

Product NDC
45865-103
11-digit product format
458650103
Labeler code
45865
Product ID
45865-103_b59becdb-e73d-2d27-e053-2995a90aa946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA211603
Marketing category
ANDA
Marketing start
2020-07-01
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
2021-12-31
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
45865-103-302025-01-30C16284748780-12cef2736-79b8-d83d-e063-dadaa90ab31fDoxepin Hydrochloride Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-103-30Doxepin Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-103DOXEPIN HYDROCHLORIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201204_b59becdb-e73c-2d27-e053-2995a90aa946.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNb59becdb-e73c-2d27-e053-2995a90aa9461
1000048doxepin 10 MG Oral CapsuleSCDb59becdb-e73c-2d27-e053-2995a90aa9461
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYb59becdb-e73c-2d27-e053-2995a90aa9461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-103-304586501033030 CAPSULE in 1 BOTTLE (45865-103-30) 30 capsule2020-07-010000-00-00NoNoCurrent