Sildenafil

Product NDC: 45865-833
11-digit product format: 458650833
Labeler code: 45865
Product ID: 45865-833_7dc93e98-6c70-c094-e053-2991aa0a19fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA203814
Marketing category: ANDA
Marketing start: 2014-01-03
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-833-30	2025-01-30	C162847	48780-1	2cef2736-7acf-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use sildenafil tablets safely and effectively. See full prescribing information for sildenafil tablets. SILDENAFIL tablets, for oral use. Initial U.S. Approval: 1998

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-833-30	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-833	SILDENAFIL TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181225_7dc93e98-6c6f-c094-e053-2991aa0a19fc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE
3M7OB98Y7H	SILDENAFIL	139755-83-2	Sildenafil

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577033	sildenafil citrate 20 MG Oral Tablet	PSN	7dc93e98-6c6f-c094-e053-2991aa0a19fc	1
577033	sildenafil 20 MG Oral Tablet	SCD	7dc93e98-6c6f-c094-e053-2991aa0a19fc	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	7dc93e98-6c6f-c094-e053-2991aa0a19fc	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-833-30	45865083330	30 TABLET, FILM COATED in 1 BOTTLE (45865-833-30)	2018-06-01	0000-00-00	No	No	Current