FDA.reportPublic FDA data

Sildenafil

Product NDC
60687-788
11-digit product format
606870788
Labeler code
60687
Product ID
60687-788_440822fa-ac1f-c2b6-e063-6294a90ab06a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203814
Marketing category
ANDA
Marketing start
2023-11-13
Substance
SILDENAFIL CITRATE
Active strength
20 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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
60687-788-11Sildenafil1 in 1 BLISTER PACKTABLET, FILM COATED17
60687-788-21Sildenafil30 in 1 CARTONTABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-788-11EA - Each60687-788f4a545f0-b395-471f-b6ef-7380f8b7d3f612023-12-05
60687-788-21EA - Each60687-78855ef3c52-4d7a-4d64-94fc-ff399fd1bb4a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-788SILDENAFIL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, 2 package rows20241219_f7fbfc3b-807e-4375-a6eb-8db0eaf40c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7
577033sildenafil 20 MG Oral TabletSCDf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-788-11606870788111 in 1 BLISTER PACKHistorical
60687-788-216068707882130 BLISTER PACK in 1 CARTON (60687-788-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-788-11) 30 blister pack2023-11-13NoNoCurrent