FDA.reportPublic FDA data

SILDENAFIL

Product NDC
71610-675
11-digit product format
716100675
Labeler code
71610
Product ID
71610-675_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
100 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 CITRATE100 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
71610-675-02SILDENAFIL2 in 1 BOTTLETABLET24
71610-675-03SILDENAFIL9 in 1 BOTTLETABLET94
71610-675-04SILDENAFIL4 in 1 BOTTLETABLET44
71610-675-06SILDENAFIL6 in 1 BOTTLETABLET64
71610-675-12SILDENAFIL12 in 1 BOTTLETABLET124
71610-675-33SILDENAFIL3 in 1 BOTTLETABLET34
71610-675-52SILDENAFIL18 in 1 BOTTLETABLET184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-675-03EA - Each71610-6750711c15b-9ab3-46d1-b64e-453c3caf7fa212024-01-04
71610-675-04EA - Each71610-675846a11d8-a863-4de9-9671-afdd3b59bd8012024-01-04
71610-675-06EA - Each71610-67595061225-10c1-4c27-95d2-939efafcb79b12023-08-08
71610-675-12EA - Each71610-6758debf1a7-144f-46b6-b011-40cc55ade2e712024-01-04
71610-675-33EA - Each71610-6753de30805-155d-417d-bdb1-a77495e23d8912023-12-05
71610-675-52EA - Each71610-675a5ec08df-d288-4c9b-8030-b41129e5aaaf12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-675SILDENAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 7 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
71610-675-02716100675022 TABLET in 1 BOTTLE (71610-675-02) 2 tablet2022-11-070000-00-00NoNoCurrent
71610-675-03716100675039 TABLET in 1 BOTTLE (71610-675-03) 9 tablet2022-11-070000-00-00NoNoCurrent
71610-675-04716100675044 TABLET in 1 BOTTLE (71610-675-04) 4 tablet2022-11-070000-00-00NoNoCurrent
71610-675-06716100675066 TABLET in 1 BOTTLE (71610-675-06) 6 tablet2022-11-070000-00-00NoNoCurrent
71610-675-127161006751212 TABLET in 1 BOTTLE (71610-675-12) 12 tablet2022-11-070000-00-00NoNoCurrent
71610-675-33716100675333 TABLET in 1 BOTTLE (71610-675-33) 3 tablet2022-12-01NoNoCurrent
71610-675-527161006755218 TABLET in 1 BOTTLE (71610-675-52) 18 tablet2022-11-070000-00-00NoNoCurrent