FDA.reportPublic FDA data

Sildenafil

Product NDC
65862-691
11-digit product format
658620691
Labeler code
65862
Product ID
65862-691_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
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
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
65862-691-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1006
65862-691-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED5006
65862-691-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-691-01EA - Each65862-69161388779-0c8e-4149-9818-e429f52f72a412018-07-03
65862-691-05EA - Each65862-691093f4987-d5e7-4683-939e-dd5f0d6e06d812024-08-12
65862-691-30EA - Each65862-691a0eadcd1-66b2-4601-82ac-122b06ea787e12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-691SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20240618_363c1e77-e482-47b2-aa1e-851abd770aeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil citrate 25 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil citrate 50 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil citrate 100 MG Oral TabletPSN0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil citrate 100 MG Oral TabletPSN61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG Oral TabletSCD0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG Oral TabletSCD61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0720268c-2c92-4632-8c55-76c254d1beb82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY61c3866e-401d-48b3-a0d2-1e24a33ab5122
314229sildenafil citrate 100 MG Oral TabletPSN3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil citrate 100 MG Oral TabletPSN18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil citrate 100 MG Oral TabletPSN41b2c017-53a0-c687-e063-6394a90a15b21
314229sildenafil 100 MG Oral TabletSCD3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil 100 MG Oral TabletSCD18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG Oral TabletSCD41b2c017-53a0-c687-e063-6394a90a15b21
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY3314d14e-99eb-39e5-e063-6394a90aed941
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY41b2c017-53a0-c687-e063-6394a90a15b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-691-0165862069101100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01) 2018-06-110000-00-00NoNoCurrent
65862-691-0565862069105500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05) 2018-06-110000-00-00NoNoCurrent
65862-691-306586206913030 TABLET, FILM COATED in 1 BOTTLE (65862-691-30) 2018-06-110000-00-00NoNoCurrent