SELEGILINE HYDROCHLORIDE

Product NDC: 67253-700
11-digit product format: 672530700
Labeler code: 67253
Product ID: 67253-700_5a997369-4215-40a1-9570-a3f9494762c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SELEGILINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA075352
Marketing category: ANDA
Marketing start: 2006-11-04
Marketing end: 2020-01-31
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: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6780a268-60d0-4c35-b9cf-cd4360ac8329	Product name	1	20190702
897f5455-61fe-1903-6c67-bd52e2f7ffbe	Product name	1	20140508
98710086-9ad6-ee93-d125-b72fb2fc859a	Product name	1	20140508

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67253-700-06	EA - Each	67253-700	307c22f9-c0ba-4f16-a5d2-f5e594383969	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SELEGILINE HYDROCHLORIDE	ACTIVE INGREDIENT	6W731X367Q	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SELEGILINE	ACTIVE MOIETY	2K1V7GP655	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6W731X367Q	SELEGILINE HYDROCHLORIDE	14611-52-0	SELEGILINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859186	selegiline HCl 5 MG Oral Capsule	PSN	dcd786c2-fdf6-46fd-b05f-1618ab6536ab	3
859186	selegiline hydrochloride 5 MG Oral Capsule	SCD	dcd786c2-fdf6-46fd-b05f-1618ab6536ab	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SELEGILINE HYDROCHLORIDE CAPSULES	Carilion Materials Management	2016-08-04	HUMAN PRESCRIPTION DRUG LABEL	3