Sildenafil

Product NDC: 50090-4644
11-digit product format: 500904644
Labeler code: 50090
Product ID: 50090-4644_cfb38b4a-1bad-471b-9005-b0cb2a8ff986
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202023
Marketing category: ANDA
Marketing start: 2018-06-28
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 25 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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
50090-4644-0	2023-01-30	C162847	48780-1	f386c649-9cff-0266-e053-dadaa90a7c1a	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
50090-4644-0	Sildenafil	10 in 1 BOTTLE	TABLET, FILM COATED	10		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4644	SILDENAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20210417_3095b2c2-d0f8-485a-aeda-ef950868c154.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
314228	sildenafil citrate 25 MG Oral Tablet	PSN	3095b2c2-d0f8-485a-aeda-ef950868c154	5
314228	sildenafil 25 MG Oral Tablet	SCD	3095b2c2-d0f8-485a-aeda-ef950868c154	5
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	3095b2c2-d0f8-485a-aeda-ef950868c154	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4644-0	50090464400	10 TABLET, FILM COATED in 1 BOTTLE (50090-4644-0)	2019-10-24	0000-00-00	No	No	Current