FDA.reportPublic FDA data

SILDENAFIL

Product NDC
55801-338
11-digit product format
558010338
Labeler code
55801
Product ID
55801-338_d97109d0-3d4e-471e-b91f-abda06395b7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
Appco Pharma LLC
Application
ANDA207178
Marketing category
ANDA
Marketing start
2023-10-05
Substance
SILDENAFIL CITRATE
Active strength
25 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 CITRATE25 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
55801-338-01SILDENAFIL30 in 1 BOTTLETABLET3010
55801-338-02SILDENAFIL100 in 1 BOTTLETABLET10010
55801-338-03SILDENAFIL500 in 1 BOTTLETABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55801-338SILDENAFIL TABLET [APPCO PHARMA LLC]9Current NDC, 3 package rows20231006_df1cc749-caec-4bf0-aa4d-db9dcc5257c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
314228sildenafil citrate 25 MG Oral TabletPSNdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
312950sildenafil citrate 50 MG Oral TabletPSNdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
314229sildenafil 100 MG Oral TabletSCDdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
314228sildenafil 25 MG Oral TabletSCDdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
312950sildenafil 50 MG Oral TabletSCDdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYdf1cc749-caec-4bf0-aa4d-db9dcc5257c310
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdf1cc749-caec-4bf0-aa4d-db9dcc5257c310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55801-338-015580103380130 TABLET in 1 BOTTLE (55801-338-01) 30 tablet2023-10-05NoNoHistorical
55801-338-0255801033802100 TABLET in 1 BOTTLE (55801-338-02) 100 tablet2023-10-05NoNoHistorical
55801-338-0355801033803500 TABLET in 1 BOTTLE (55801-338-03) 500 tablet2023-10-05NoNoHistorical