FDA.reportPublic FDA data

Selegiline Hydrochloride

Product NDC
71205-888
11-digit product format
712050888
Labeler code
71205
Product ID
71205-888_a8be3ead-1645-4f63-8683-46e29fdb3041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
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
71205-888-00Selegiline Hydrochloride100 in 1 BOTTLECAPSULE1002
71205-888-11Selegiline Hydrochloride1000 in 1 BOTTLECAPSULE10002
71205-888-30Selegiline Hydrochloride30 in 1 BOTTLECAPSULE302
71205-888-55Selegiline Hydrochloride500 in 1 BOTTLECAPSULE5002
71205-888-60Selegiline Hydrochloride60 in 1 BOTTLECAPSULE602
71205-888-90Selegiline Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-888-00EA - Each71205-8880fa65cbe-9074-40ff-9ccd-d818c61e7c6012021-09-07
71205-888-11EA - Each71205-888dc32a5d7-b643-4e33-8e6a-d224517a29da12021-09-07
71205-888-30EA - Each71205-88840d5229a-e997-4fc5-b7ff-7f0736797b0912021-09-07
71205-888-55EA - Each71205-8887d2e19d2-1fa9-421c-b453-d2dca0cb938512021-09-07
71205-888-60EA - Each71205-888d6470289-d612-4685-b981-42319eda9c6712021-09-07
71205-888-90EA - Each71205-88832d82e95-7a79-4141-841f-1c32d2e6b76112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-888SELEGILINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220415_57b564ef-c89b-4cf6-a11f-f67391d74e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSN57b564ef-c89b-4cf6-a11f-f67391d74e7e2
859186selegiline hydrochloride 5 MG Oral CapsuleSCD57b564ef-c89b-4cf6-a11f-f67391d74e7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-888-0071205088800100 CAPSULE in 1 BOTTLE (71205-888-00) 100 capsule2021-08-030000-00-00NoNoCurrent
71205-888-11712050888111000 CAPSULE in 1 BOTTLE (71205-888-11) 1000 capsule2021-08-030000-00-00NoNoCurrent
71205-888-307120508883030 CAPSULE in 1 BOTTLE (71205-888-30) 30 capsule2021-08-030000-00-00NoNoCurrent
71205-888-5571205088855500 CAPSULE in 1 BOTTLE (71205-888-55) 500 capsule2021-08-030000-00-00NoNoCurrent
71205-888-607120508886060 CAPSULE in 1 BOTTLE (71205-888-60) 60 capsule2021-08-030000-00-00NoNoCurrent
71205-888-907120508889090 CAPSULE in 1 BOTTLE (71205-888-90) 90 capsule2021-08-030000-00-00NoNoCurrent