Bicalutamide

Product NDC: 60505-2642
11-digit product format: 605052642
Labeler code: 60505
Product ID: 60505-2642_7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA078917
Marketing category: ANDA
Marketing start: 2009-07-06
Marketing end: 0000-00-00
Substance: BICALUTAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
18edadb0-25ee-467f-798d-437ee65ee754	Product name	3	20150616

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60505-2642-1	2020-01-31	C162847	48780-1	9d75b9d0-13e1-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval : 1995
60505-2642-3	2020-01-31	C162847	48780-1	9d75b9d0-13e1-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval : 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-2642-1	Bicalutamide	100 in 1 BOTTLE	TABLET	100		1
60505-2642-3	Bicalutamide	30 in 1 BOTTLE	TABLET	30		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-2642-1	EA - Each	60505-2642	69100839-d6ea-4d8a-a148-250a97c446a8	1	2013-02-13
60505-2642-3	EA - Each	60505-2642	286f4316-f58c-4866-a886-820728726221	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BICALUTAMIDE	ACTIVE INGREDIENT	A0Z3NAU9DP	BICALUTAMIDE TABLET [APOTEX CORP.]	1
BICALUTAMIDE	ACTIVE MOIETY	A0Z3NAU9DP	BICALUTAMIDE TABLET [APOTEX CORP.]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BICALUTAMIDE TABLET [APOTEX CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BICALUTAMIDE TABLET [APOTEX CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BICALUTAMIDE TABLET [APOTEX CORP.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BICALUTAMIDE TABLET [APOTEX CORP.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	BICALUTAMIDE TABLET [APOTEX CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BICALUTAMIDE TABLET [APOTEX CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BICALUTAMIDE TABLET [APOTEX CORP.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-2642	BICALUTAMIDE TABLET [APOTEX CORP.]	1	Legacy NDC, 2 package rows	20120823_7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A0Z3NAU9DP	BICALUTAMIDE	90357-06-5	BICALUTAMIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199123	bicalutamide 50 MG Oral Tablet	PSN	7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75	1
199123	bicalutamide 50 MG Oral Tablet	SCD	7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
60505-2642-1	60505264201	100 in 1 BOTTLE	Historical
60505-2642-3	60505264203	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bicalutamide	Apotex Corp. \| Intas Pharmaceuticals Limited	2012-08-22	HUMAN PRESCRIPTION DRUG LABEL	1