FDA.reportPublic FDA data

Sildenafil

Product NDC
31722-711
11-digit product format
317220711
Labeler code
31722
Product ID
31722-711_5267627d-d2da-7e37-e063-6394a90a9f10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202659
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
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 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
31722-711-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1003
31722-711-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED5003
31722-711-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-711-01EA - Each31722-711415f8094-aec1-4994-84db-df9ec721801e12018-07-03
31722-711-05EA - Each31722-71172068af2-9110-484e-ae26-1d2ad1c6f67812025-05-14
31722-711-30EA - Each31722-7118f186706-9abb-4102-a17a-eab73fa3b4cd12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-711SILDENAFIL TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 3 package rows20180620_dc1c1ddb-f16b-4d7a-aabe-cf8bdf8b7998.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf66ce83b-bad6-4180-a8c4-8475a8ec50b7105
314229sildenafil 100 MG Oral TabletSCDf66ce83b-bad6-4180-a8c4-8475a8ec50b7105
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf66ce83b-bad6-4180-a8c4-8475a8ec50b7105
314229sildenafil citrate 100 MG Oral TabletPSNe1af7b6a-378e-4337-858f-85a926eec1029
314229sildenafil 100 MG Oral TabletSCDe1af7b6a-378e-4337-858f-85a926eec1029
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYe1af7b6a-378e-4337-858f-85a926eec1029
314229sildenafil citrate 100 MG Oral TabletPSN78101030-ef1d-44b9-e053-2991aa0a158d7
314229sildenafil 100 MG Oral TabletSCD78101030-ef1d-44b9-e053-2991aa0a158d7
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY78101030-ef1d-44b9-e053-2991aa0a158d7
314229sildenafil citrate 100 MG Oral TabletPSNeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6
314229sildenafil 100 MG Oral TabletSCDeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYeaeab74e-38cc-4621-9ce8-8a5d74a29a9e6
314229sildenafil citrate 100 MG Oral TabletPSN7925711e-2e89-fd93-e053-2991aa0a507f5
314229sildenafil citrate 100 MG Oral TabletPSN174ef537-e3e6-42bd-a478-47b930ddc7615
314229sildenafil 100 MG Oral TabletSCD7925711e-2e89-fd93-e053-2991aa0a507f5
314229sildenafil 100 MG Oral TabletSCD174ef537-e3e6-42bd-a478-47b930ddc7615
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7925711e-2e89-fd93-e053-2991aa0a507f5
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY174ef537-e3e6-42bd-a478-47b930ddc7615
314229sildenafil citrate 100 MG Oral TabletPSNa84a418a-155c-7be7-e053-2995a90a81584
314229sildenafil 100 MG Oral TabletSCDa84a418a-155c-7be7-e053-2995a90a81584
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYa84a418a-155c-7be7-e053-2995a90a81584
314229sildenafil citrate 100 MG Oral TabletPSNce273b80-0509-4853-bd6d-2b64c0a53ef83
314229sildenafil citrate 100 MG Oral TabletPSN0aced3eb-cb0b-4135-905c-b274505aa7403
314229sildenafil citrate 100 MG Oral TabletPSNdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314228sildenafil citrate 25 MG Oral TabletPSNdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil citrate 50 MG Oral TabletPSNce273b80-0509-4853-bd6d-2b64c0a53ef83
312950sildenafil citrate 50 MG Oral TabletPSNdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314229sildenafil 100 MG Oral TabletSCDdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314229sildenafil 100 MG Oral TabletSCDce273b80-0509-4853-bd6d-2b64c0a53ef83
314229sildenafil 100 MG Oral TabletSCD0aced3eb-cb0b-4135-905c-b274505aa7403
314228sildenafil 25 MG Oral TabletSCDdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil 50 MG Oral TabletSCDdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil 50 MG Oral TabletSCDce273b80-0509-4853-bd6d-2b64c0a53ef83
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0aced3eb-cb0b-4135-905c-b274505aa7403
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYce273b80-0509-4853-bd6d-2b64c0a53ef83
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYce273b80-0509-4853-bd6d-2b64c0a53ef83
314229sildenafil citrate 100 MG Oral TabletPSNf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG Oral TabletSCDf3089ee6-190d-4749-e053-2a95a90a15d82
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf3089ee6-190d-4749-e053-2a95a90a15d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-711-0131722071101100 TABLET, FILM COATED in 1 BOTTLE (31722-711-01) 2018-06-110000-00-00NoNoCurrent
31722-711-0531722071105500 TABLET, FILM COATED in 1 BOTTLE (31722-711-05) 2018-06-110000-00-00NoNoCurrent
31722-711-303172207113030 TABLET, FILM COATED in 1 BOTTLE (31722-711-30) 2018-06-110000-00-00NoNoCurrent