FDA.reportPublic FDA data

Sildenafil

Product NDC
71205-088
11-digit product format
712050088
Labeler code
71205
Product ID
71205-088_ebc2e212-b59d-464c-a0cd-ede59263c5da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077342
Marketing category
ANDA
Marketing start
2017-12-11
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
Rxcui314229

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-088-10Sildenafil10 in 1 BOTTLETABLET, FILM COATED105
71205-088-20Sildenafil20 in 1 BOTTLETABLET, FILM COATED205
71205-088-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED305
71205-088-50Sildenafil50 in 1 BOTTLETABLET, FILM COATED505
71205-088-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED605
71205-088-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-088-20EA - Each71205-088fd80ed27-85ac-460e-94aa-9bc9b2890a3912021-06-02
71205-088-30EA - Each71205-0883d2a569f-737a-4dd8-9c5e-deb308937bbe12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-088SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 6 package rows20210501_43a036a4-8a34-4411-ac8e-bf5063d67d48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN43a036a4-8a34-4411-ac8e-bf5063d67d485
314229sildenafil 100 MG Oral TabletSCD43a036a4-8a34-4411-ac8e-bf5063d67d485
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY43a036a4-8a34-4411-ac8e-bf5063d67d485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-088-107120500881010 TABLET, FILM COATED in 1 BOTTLE (71205-088-10) 2018-08-010000-00-00NoNoCurrent
71205-088-207120500882020 TABLET, FILM COATED in 1 BOTTLE (71205-088-20) 2021-04-210000-00-00NoNoCurrent
71205-088-307120500883030 TABLET, FILM COATED in 1 BOTTLE (71205-088-30) 2018-08-010000-00-00NoNoCurrent
71205-088-507120500885050 TABLET, FILM COATED in 1 BOTTLE (71205-088-50) 2018-08-010000-00-00NoNoCurrent
71205-088-607120500886060 TABLET, FILM COATED in 1 BOTTLE (71205-088-60) 2018-08-010000-00-00NoNoCurrent
71205-088-907120500889090 TABLET, FILM COATED in 1 BOTTLE (71205-088-90) 2018-08-010000-00-00NoNoCurrent