SILDENAFIL CITRATE

Product NDC
70518-1641
11-digit product format
705181641
Labeler code
70518
Product ID
70518-1641_e5bc6bc7-9b3e-c93b-e053-2a95a90a8dd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091448
Marketing category
ANDA
Marketing start
2018-11-07
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
50 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 conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1641SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [REMEDYREPACK INC.]13Legacy NDC20250226_cac4f544-536c-4886-a379-99eed2d35240.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1641-07051816410030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1641-0) 2018-11-070000-00-00NoNoCurrent