FDA.reportPublic FDA data

Selegiline Hydrochloride

Product NDC
50090-2918
11-digit product format
500902918
Labeler code
50090
Product ID
50090-2918_8fb333d4-21ac-4598-9e18-2a46d718569c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074871
Marketing category
ANDA
Marketing start
1997-07-06
Substance
SELEGILINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Selegiline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEGILINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6W731X367Q
Rxcui859193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2918-02023-02-07C16284748780-1f386c649-e7fb-0266-e053-dadaa90a7c1aSelegiline Hydrochloride Tablets USP 5 mg
50090-2918-02023-01-30C16284748780-1f386c649-e7fb-0266-e053-dadaa90a7c1aSelegiline Hydrochloride Tablets USP 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2918-0Selegiline Hydrochloride4 in 1 BOTTLETABLET49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2918-0EA - Each50090-2918ba8b766e-3f0f-42ff-aaa3-4c19db10981c12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2918SELEGILINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230208_f286c854-3b8c-44a8-b3b5-c828dbabb207.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859193selegiline HCl 5 MG Oral TabletPSNf286c854-3b8c-44a8-b3b5-c828dbabb2079
859193selegiline hydrochloride 5 MG Oral TabletSCDf286c854-3b8c-44a8-b3b5-c828dbabb2079

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2918-0500902918004 TABLET in 1 BOTTLE (50090-2918-0) 4 tablet2017-03-140000-00-00NoNoCurrent