FDA.reportPublic FDA data

Selegiline Hydrochloride

Product NDC
16571-659
11-digit product format
165710659
Labeler code
16571
Product ID
16571-659_102210a0-2a43-44c4-aedf-7741b84675ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206803
Marketing category
ANDA
Marketing start
2019-04-02
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-659-06Selegiline Hydrochloride60 in 1 BOTTLECAPSULE603
16571-659-50Selegiline Hydrochloride500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-659-06EA - Each16571-6598468740f-4202-4ec4-a7c4-12910fe7293b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-659SELEGILINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 2 package rows20240809_23c4481f-d150-40c6-addb-b3e454ca914f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSN23c4481f-d150-40c6-addb-b3e454ca914f3
859186selegiline hydrochloride 5 MG Oral CapsuleSCD23c4481f-d150-40c6-addb-b3e454ca914f3
859186selegiline HCl 5 MG Oral CapsulePSN57b564ef-c89b-4cf6-a11f-f67391d74e7e2
859186selegiline hydrochloride 5 MG Oral CapsuleSCD57b564ef-c89b-4cf6-a11f-f67391d74e7e2
859186selegiline HCl 5 MG Oral CapsulePSN4848270a-1179-410c-b4e6-a7e555b3a9881
859186selegiline hydrochloride 5 MG Oral CapsuleSCD4848270a-1179-410c-b4e6-a7e555b3a9881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-659-061657106590660 CAPSULE in 1 BOTTLE (16571-659-06) 60 capsule2019-04-020000-00-00NoNoCurrent
16571-659-5016571065950500 CAPSULE in 1 BOTTLE (16571-659-50) 500 capsule2019-04-020000-00-00NoNoCurrent