SILDENAFIL

Product NDC
61919-826
11-digit product format
619190826
Labeler code
61919
Product ID
61919-826_eac53773-083b-5f20-e053-2a95a90a2b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA203814
Marketing category
ANDA
Marketing start
2016-08-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
61919-826-102025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-202025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-302025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-502025-01-30C16284748780-12cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-902020-01-31C16284748780-19d75b9d0-d273-f424-e053-dadaa90a57ceSILDENAFIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-826-10SILDENAFIL10 in 1 BOTTLETABLET, FILM COATED1011
61919-826-20SILDENAFIL20 in 1 BOTTLETABLET, FILM COATED2011
61919-826-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED3011
61919-826-50SILDENAFIL50 in 1 BOTTLETABLET, FILM COATED5011
61919-826-90SILDENAFIL90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-826-10EA - Each61919-8261f59faa3-c0ef-466b-8825-5b3e693c7cd912019-11-12
61919-826-15EA - Each61919-826e8159d6a-6fe5-4fad-98fb-c3bd3aadbf8312019-11-12
61919-826-20EA - Each61919-8261f6b53a1-952b-4f54-ae72-1808f1eb8f0e12022-11-07
61919-826-30EA - Each61919-826579f2eb5-f837-4117-a94d-2895d0177d2512019-11-12
61919-826-50EA - Each61919-8263536b2d8-adb3-4db6-a9c0-940a274c952d12019-08-06
61919-826-90EA - Each61919-82640557455-f8e7-42a6-a608-3dcf09640d3412016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-826SILDENAFIL TABLET, FILM COATED [DIRECT RX]11Legacy NDC, 4 package rows20230524_3b3aae0f-4d1d-0244-e054-00144ff88e88.zip
61919-826SILDENAFIL TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20151020_c152953d-53a0-4f8b-91d7-fcd94024ad49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil citrate 50 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil citrate 20 MG Oral TabletPSNc152953d-53a0-4f8b-91d7-fcd94024ad491
577033sildenafil 20 MG Oral TabletSCDc152953d-53a0-4f8b-91d7-fcd94024ad491
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc152953d-53a0-4f8b-91d7-fcd94024ad491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-826-106191908261010 TABLET, FILM COATED in 1 BOTTLE (61919-826-10) 2016-08-290000-00-00NoNoCurrent
61919-826-206191908262020 TABLET, FILM COATED in 1 BOTTLE (61919-826-20) 2016-08-290000-00-00NoNoCurrent
61919-826-306191908263030 TABLET, FILM COATED in 1 BOTTLE (61919-826-30) 2022-09-270000-00-00NoNoCurrent
61919-826-506191908265050 TABLET, FILM COATED in 1 BOTTLE (61919-826-50) 2016-08-290000-00-00NoNoCurrent
61919-826-906191908269090 in 1 BOTTLEHistorical