Sildenafil Citrate

Product NDC
70954-408
11-digit product format
709540408
Labeler code
70954
Product ID
70954-408_6d8dbaa6-d61a-46ae-a641-f664104f4714
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil Citrate
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA216383
Marketing category
ANDA
Marketing start
2023-08-29
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 Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 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
70954-408-10Sildenafil Citrate30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-408SILDENAFIL CITRATE TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20230906_6d8dbaa6-d61a-46ae-a641-f664104f4714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN6d8dbaa6-d61a-46ae-a641-f664104f47141
314228sildenafil citrate 25 MG Oral TabletPSN6d8dbaa6-d61a-46ae-a641-f664104f47141
312950sildenafil citrate 50 MG Oral TabletPSN6d8dbaa6-d61a-46ae-a641-f664104f47141
314229sildenafil 100 MG Oral TabletSCD6d8dbaa6-d61a-46ae-a641-f664104f47141
314228sildenafil 25 MG Oral TabletSCD6d8dbaa6-d61a-46ae-a641-f664104f47141
312950sildenafil 50 MG Oral TabletSCD6d8dbaa6-d61a-46ae-a641-f664104f47141
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY6d8dbaa6-d61a-46ae-a641-f664104f47141
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY6d8dbaa6-d61a-46ae-a641-f664104f47141
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY6d8dbaa6-d61a-46ae-a641-f664104f47141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-408-107095404081030 TABLET in 1 BOTTLE (70954-408-10) 30 tablet2023-08-29NoNoHistorical