Sildenafil

Product NDC
43063-676
11-digit product format
430630676
Labeler code
43063
Product ID
43063-676_e698855d-83e2-7e37-e053-2995a90ab312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx 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 conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-676-10EA - Each43063-67677a2f3c6-fc8b-45c8-8418-bb02b406db7112016-09-02
43063-676-30EA - Each43063-676fe8391f9-e533-4c84-841b-13a0d3297bef12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-676SILDENAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Legacy NDC20241016_cb012bc0-7256-446c-b6e3-0be428cdd9ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-676-104306306761010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-676-10) 2016-08-150000-00-00NoNoCurrent
43063-676-304306306763030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-676-30) 2016-06-090000-00-00NoNoCurrent