FDA.reportPublic FDA data

Sildenafil for Oral Suspension

Product NDC
72205-035
11-digit product format
722050035
Labeler code
72205
Product ID
72205-035_9ada0833-04f4-4ce1-b13c-71e074714f05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213041
Marketing category
ANDA
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
10 mg/mL
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72205-035-762022-01-28C16284748780-1d6a99b39-ae9a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SILDENAFIL FOR ORAL SUSPENSION safely and effectively. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL for oral suspension Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-035-76Sildenafil for Oral Suspension112 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1122
72205-035-76Sildenafil for Oral Suspension1 in 1 CARTONPOWDER, FOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-035-76ML - Milliliter72205-035bd632e15-d878-4401-aa93-321b9a6d90e012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-035SILDENAFIL FOR ORAL SUSPENSION (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [NOVADOZ PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20200901_7b244dfc-ac09-4442-bb16-02fdc40564a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN7b244dfc-ac09-4442-bb16-02fdc40564a02
1307427sildenafil 10 MG/ML Oral SuspensionSCD7b244dfc-ac09-4442-bb16-02fdc40564a02
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY7b244dfc-ac09-4442-bb16-02fdc40564a02
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY7b244dfc-ac09-4442-bb16-02fdc40564a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-035-76722050035761 BOTTLE in 1 CARTON (72205-035-76) > 112 mL in 1 BOTTLE1 bottle2020-09-010000-00-00NoNoCurrent