Doxepin Hydrochloride

Product NDC
68071-2314
11-digit product format
680712314
Labeler code
68071
Product ID
68071-2314_d59041e0-10e8-a739-e053-2a95a90aa8e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA070791
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
No
Listing certified through
2023-12-31
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
68071-2314-12025-01-30C16284748780-12cef2736-70b7-d83d-e063-dadaa90ab31fb638266b-bc89-144f-e053-2995a90a1714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2314-1Doxepin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2314DOXEPIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20220115_b638266b-bc89-144f-e053-2995a90a1714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000048doxepin HCl 10 MG Oral CapsulePSNb638266b-bc89-144f-e053-2995a90a17142
1000048doxepin 10 MG Oral CapsuleSCDb638266b-bc89-144f-e053-2995a90a17142
1000048doxepin (as doxepin HCl) 10 MG Oral CapsuleSYb638266b-bc89-144f-e053-2995a90a17142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2314-168071231401100 CAPSULE in 1 BOTTLE, PLASTIC (68071-2314-1) 100 capsule2020-12-110000-00-00NoNoCurrent