Selegiline Hydrochloride

Product NDC
72319-006
11-digit product format
723190006
Labeler code
72319
Product ID
72319-006_248576e6-bc11-e847-e063-6294a90afe9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA074672
Marketing category
ANDA
Marketing start
2021-12-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72319-006-02Selegiline Hydrochloride60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72319-006-02EA - Each72319-006960cf804-076a-4601-a83b-e20f2105015c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-006SELEGILINE HYDROCHLORIDE TABLET [I3 PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20241116_c81e983b-455d-2e65-e053-2a95a90a3123.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859193selegiline HCl 5 MG Oral TabletPSNc81e983b-455d-2e65-e053-2a95a90a31235
859193selegiline hydrochloride 5 MG Oral TabletSCDc81e983b-455d-2e65-e053-2a95a90a31235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72319-006-027231900060260 TABLET in 1 BOTTLE (72319-006-02) 60 tablet2021-12-150000-00-00NoNoCurrent