FDA.reportPublic FDA data

Sildenafil

Product NDC
31722-966
11-digit product format
317220966
Labeler code
31722
Product ID
31722-966_52114a2a-181f-38a9-e063-6394a90a7ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2019-08-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-966-012025-01-30C16284748780-12cef2736-940a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
31722-966-302025-01-30C16284748780-12cef2736-940a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-966-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1002
31722-966-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-966SILDENAFIL TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20190802_96ab1605-e171-4e86-b357-2d9378f7a05a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN96ab1605-e171-4e86-b357-2d9378f7a05a2
314228sildenafil citrate 25 MG Oral TabletPSN96ab1605-e171-4e86-b357-2d9378f7a05a2
312950sildenafil citrate 50 MG Oral TabletPSN96ab1605-e171-4e86-b357-2d9378f7a05a2
314229sildenafil 100 MG Oral TabletSCD96ab1605-e171-4e86-b357-2d9378f7a05a2
314228sildenafil 25 MG Oral TabletSCD96ab1605-e171-4e86-b357-2d9378f7a05a2
312950sildenafil 50 MG Oral TabletSCD96ab1605-e171-4e86-b357-2d9378f7a05a2
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY96ab1605-e171-4e86-b357-2d9378f7a05a2
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY96ab1605-e171-4e86-b357-2d9378f7a05a2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY96ab1605-e171-4e86-b357-2d9378f7a05a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-966-0131722096601100 TABLET, FILM COATED in 1 BOTTLE (31722-966-01) 2019-08-010000-00-00NoNoCurrent
31722-966-303172209663030 TABLET, FILM COATED in 1 BOTTLE (31722-966-30) 2019-08-010000-00-00NoNoCurrent