FDA.reportPublic FDA data

Selegiline Hydrochloride

Product NDC
70954-504
11-digit product format
709540504
Labeler code
70954
Product ID
70954-504_e42d99b0-c62e-49d4-b792-1301bb539b92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA075352
Marketing category
ANDA
Marketing start
2021-04-01
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
Rxcui859186

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
70954-504-10Selegiline Hydrochloride60 in 1 BOTTLECAPSULE601
70954-504-20Selegiline Hydrochloride1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-504-10EA - Each70954-50423535d19-8107-4bd0-867d-f2b7528a46c212021-05-05
70954-504-20EA - Each70954-504bffd5776-d47b-4f8e-8a80-47188ab9b6c912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-504SELEGILINE HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 2 package rows20210403_e42d99b0-c62e-49d4-b792-1301bb539b92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSNdf88d6bf-0fda-3825-e053-2a95a90a3a754
859186selegiline hydrochloride 5 MG Oral CapsuleSCDdf88d6bf-0fda-3825-e053-2a95a90a3a754
859186selegiline HCl 5 MG Oral CapsulePSNb8eb0a00-adc7-4aaf-987c-fa1b207b29961
859186selegiline HCl 5 MG Oral CapsulePSNe42d99b0-c62e-49d4-b792-1301bb539b921
859186selegiline hydrochloride 5 MG Oral CapsuleSCDb8eb0a00-adc7-4aaf-987c-fa1b207b29961
859186selegiline hydrochloride 5 MG Oral CapsuleSCDe42d99b0-c62e-49d4-b792-1301bb539b921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-504-107095405041060 CAPSULE in 1 BOTTLE (70954-504-10) 60 capsule2021-04-010000-00-00NoNoCurrent
70954-504-20709540504201000 CAPSULE in 1 BOTTLE (70954-504-20) 1000 capsule2021-04-010000-00-00NoNoCurrent