Sildenafil

Product NDC
0378-1657
11-digit product format
003781657
Labeler code
0378
Product ID
0378-1657_17c6b6b9-ad60-40f8-b7f0-1ce76954ab57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildinafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201150
Marketing category
ANDA
Marketing start
2012-11-09
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1657-77EA - Each0378-165780c146fb-9ece-4154-ab41-27c36a1dfebd12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1657-770037816577790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1657-77) 2012-11-090000-00-00NoNoCurrent