FDA.reportPublic FDA data

SILDENAFIL

Product NDC
71610-679
11-digit product format
716100679
Labeler code
71610
Product ID
71610-679_f4dbdb1b-c31d-4418-abd9-883eef04d5bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA207178
Marketing category
ANDA
Marketing start
2022-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314229

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-679-02SILDENAFIL2 in 1 BOTTLETABLET24
71610-679-04SILDENAFIL4 in 1 BOTTLETABLET44
71610-679-06SILDENAFIL6 in 1 BOTTLETABLET64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-679-02EA - Each71610-67983626754-067e-4686-be62-98d351a2160312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-679SILDENAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 3 package rows20231110_cdab7ef5-39cb-45cc-b2bf-5f634f2f5499.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil citrate 50 MG Oral TabletPSNcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
314229sildenafil 100 MG Oral TabletSCDcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil 50 MG Oral TabletSCDcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYcdab7ef5-39cb-45cc-b2bf-5f634f2f54994
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYcdab7ef5-39cb-45cc-b2bf-5f634f2f54994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-679-02716100679022 TABLET in 1 BOTTLE (71610-679-02) 2 tablet2022-12-020000-00-00NoNoCurrent
71610-679-04716100679044 TABLET in 1 BOTTLE (71610-679-04) 4 tablet2022-12-130000-00-00NoNoCurrent
71610-679-06716100679066 TABLET in 1 BOTTLE (71610-679-06) 6 tablet2022-12-130000-00-00NoNoCurrent