Doxepin Hydrochloride

Product NDC
50090-0278
11-digit product format
500900278
Labeler code
50090
Product ID
50090-0278_e52a966f-e3f5-483c-9936-2ff0458b2107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxepin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070791
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
Substance
DOXEPIN HYDROCHLORIDE
Active strength
50 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
50090-0278-02023-01-30C16284748780-1f386c649-9fa0-0266-e053-dadaa90a7c1add01eda4-5447-44a9-8efe-cf7257278fa3
50090-0278-12023-01-30C16284748780-1f386c649-9fa0-0266-e053-dadaa90a7c1add01eda4-5447-44a9-8efe-cf7257278fa3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0278-0Doxepin Hydrochloride100 in 1 BOTTLECAPSULE10014
50090-0278-1Doxepin Hydrochloride30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0278-1EA - Each50090-0278bc8f01e2-744c-47f7-be64-ef94ec604c6c12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0278DOXEPIN HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]14Legacy NDC, 2 package rows20200122_dd01eda4-5447-44a9-8efe-cf7257278fa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000076doxepin HCl 50 MG Oral CapsulePSNdd01eda4-5447-44a9-8efe-cf7257278fa314
1000076doxepin 50 MG Oral CapsuleSCDdd01eda4-5447-44a9-8efe-cf7257278fa314
1000076doxepin (as doxepin HCl) 50 MG Oral CapsuleSYdd01eda4-5447-44a9-8efe-cf7257278fa314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0278-050090027800100 CAPSULE in 1 BOTTLE (50090-0278-0) 100 capsule2018-10-080000-00-00NoNoCurrent
50090-0278-15009002780130 CAPSULE in 1 BOTTLE (50090-0278-1) 30 capsule2016-06-290000-00-00NoNoCurrent