Sildenafil

Product NDC: 53002-2719
11-digit product format: 530022719
Labeler code: 53002
Product ID: 53002-2719_90ddbeb1-19e8-42d1-a112-41a3b4ec5041
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
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: 2023-12-31
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
53002-2719-3	2025-01-30	C162847	48780-1	2cef2736-9f99-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
53002-2719-3	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2719	SILDENAFIL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20220331_6939f4cc-45d8-45b7-8fd9-9d384aa43a5a.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	6939f4cc-45d8-45b7-8fd9-9d384aa43a5a	1
577033	sildenafil 20 MG Oral Tablet	SCD	6939f4cc-45d8-45b7-8fd9-9d384aa43a5a	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	6939f4cc-45d8-45b7-8fd9-9d384aa43a5a	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2719-3	53002271903	30 TABLET, FILM COATED in 1 BOTTLE (53002-2719-3)	2022-08-01	0000-00-00	No	No	Current