FDA.reportPublic FDA data

Sildenafil

Product NDC
31722-710
11-digit product format
317220710
Labeler code
31722
Product ID
31722-710_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
50 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 CITRATE50 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
31722-710-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1003
31722-710-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED5003
31722-710-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-710-01EA - Each31722-710cd4f426d-3a59-436b-a93f-320b70f5ab7512018-07-03
31722-710-30EA - Each31722-71082abe6b1-140f-4567-bc12-8d84c44532c712018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-710SILDENAFIL 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
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
312950sildenafil citrate 50 MG Oral TabletPSN99bc66a4-05d1-4372-a25a-1153d7af580e10
312950sildenafil 50 MG Oral TabletSCD99bc66a4-05d1-4372-a25a-1153d7af580e10
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY99bc66a4-05d1-4372-a25a-1153d7af580e10
312950sildenafil citrate 50 MG Oral TabletPSN4e3034af-bee5-4df4-8beb-fbd2b510ad739
312950sildenafil 50 MG Oral TabletSCD4e3034af-bee5-4df4-8beb-fbd2b510ad739
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY4e3034af-bee5-4df4-8beb-fbd2b510ad739
312950sildenafil citrate 50 MG Oral TabletPSNe22902bd-e5a8-4df6-ae77-8a0a1484cc508
312950sildenafil citrate 50 MG Oral TabletPSN997197bf-7706-4e12-97df-b0a9ea6d3a108
312950sildenafil 50 MG Oral TabletSCDe22902bd-e5a8-4df6-ae77-8a0a1484cc508
312950sildenafil 50 MG Oral TabletSCD997197bf-7706-4e12-97df-b0a9ea6d3a108
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY997197bf-7706-4e12-97df-b0a9ea6d3a108
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYe22902bd-e5a8-4df6-ae77-8a0a1484cc508
312950sildenafil citrate 50 MG Oral TabletPSN7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd4
312950sildenafil 50 MG Oral TabletSCD7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd4
314229sildenafil citrate 100 MG Oral TabletPSNdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314229sildenafil citrate 100 MG Oral TabletPSNce273b80-0509-4853-bd6d-2b64c0a53ef83
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
314228sildenafil 25 MG Oral TabletSCDdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
312950sildenafil 50 MG Oral TabletSCDce273b80-0509-4853-bd6d-2b64c0a53ef83
312950sildenafil 50 MG Oral TabletSCDdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYce273b80-0509-4853-bd6d-2b64c0a53ef83
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYdc1c1ddb-f16b-4d7a-aabe-cf8bdf8b79983
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
312950sildenafil citrate 50 MG Oral TabletPSN5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2
312950sildenafil citrate 50 MG Oral TabletPSNcf34447b-214b-2e11-e053-2a95a90a5fcc2
312950sildenafil 50 MG Oral TabletSCDcf34447b-214b-2e11-e053-2a95a90a5fcc2
312950sildenafil 50 MG Oral TabletSCD5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYcf34447b-214b-2e11-e053-2a95a90a5fcc2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-710-0131722071001100 TABLET, FILM COATED in 1 BOTTLE (31722-710-01) 2018-06-110000-00-00NoNoCurrent
31722-710-0531722071005500 TABLET, FILM COATED in 1 BOTTLE (31722-710-05) 2018-06-110000-00-00NoNoCurrent
31722-710-303172207103030 TABLET, FILM COATED in 1 BOTTLE (31722-710-30) 2018-06-110000-00-00NoNoCurrent