Sildenafil

Product NDC
0378-1660
11-digit product format
003781660
Labeler code
0378
Product ID
0378-1660_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201171
Marketing category
ANDA
Marketing start
2019-04-04
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
100 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1660-93EA - Each0378-1660aba8cfb7-441a-4985-b732-f7f5411bc01c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1660SILDENAFIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4Legacy NDC20250215_cad6e3ac-84e5-4dae-9c26-8f6078f0da0c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1660-930037816609330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1660-93) 2019-04-040000-00-00NoNoCurrent