Sildenafil

Product NDC
68001-363
11-digit product format
680010363
Labeler code
68001
Product ID
68001-363_28da809a-99b6-e220-e063-6294a90ac8ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA203814
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
2027-10-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil

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
68001-363-05Sildenafil90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-363-05EA - Each68001-363e9e06eec-b71e-4880-a9d9-28a58079d38512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-363SILDENAFIL TABLET, FILM COATED [BLUEPOINT LABORATORIES]10Current NDC, Legacy NDC, 1 package rows20241213_be6d1015-306d-44fb-8d4d-01724b8d9590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNbe6d1015-306d-44fb-8d4d-01724b8d959010
577033sildenafil 20 MG Oral TabletSCDbe6d1015-306d-44fb-8d4d-01724b8d959010
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYbe6d1015-306d-44fb-8d4d-01724b8d959010
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-363-056800103630590 TABLET, FILM COATED in 1 BOTTLE (68001-363-05) 2018-09-142027-10-31NoNoCurrent