Vybrique

Product NDC
71858-0205
11-digit product format
718580205
Labeler code
71858
Product ID
71858-0205_4bb77632-4747-6bd7-e063-6294a90ae54e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
FILM
Route
ORAL
Labeler
IBSA Pharma Inc.
Application
NDA210858
Marketing category
NDA
Marketing start
2026-02-15
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
Vybrique
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui2735815, 2735821, 2735822, 2735824, 2735825, 2735827, 2735829, 2735831

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
71858-0205-2Vybrique1 in 1 POUCHFILM18
71858-0205-4Vybrique1 in 1 POUCHFILM18
71858-0205-5Vybrique4 in 1 CARTONFILM48
71858-0205-5Vybrique1 in 1 POUCHFILM18
71858-0205-6Vybrique1 in 1 POUCHFILM18
71858-0205-6Vybrique8 in 1 CARTONFILM88

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0205-5EA - Each71858-02052c30a260-6eb7-4b57-8eb8-230830043d0612026-03-17
71858-0205-6EA - Each71858-0205f7179160-becd-401d-bbe2-3a14fe537c7b12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2735815sildenafil 100 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735822sildenafil 25 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735825sildenafil 50 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735829sildenafil 75 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735821Vybrique 100 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735824vybrique 25 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735827vybrique 50 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735831vybrique 75 MG Oral FilmPSN9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735821sildenafil 100 MG Oral Film [Vybrique]SBD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735824sildenafil 25 MG Oral Film [Vybrique]SBD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735827sildenafil 50 MG Oral Film [Vybrique]SBD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735831sildenafil 75 MG Oral Film [Vybrique]SBD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735815sildenafil 100 MG Oral FilmSCD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735822sildenafil 25 MG Oral FilmSCD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735825sildenafil 50 MG Oral FilmSCD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735829sildenafil 75 MG Oral FilmSCD9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735815sildenafil (as sildenafil citrate) 100 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735822sildenafil (as sildenafil citrate) 25 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735825sildenafil (as sildenafil citrate) 50 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735829sildenafil (as sildenafil citrate) 75 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735821Vybrique (as sildenafil citrate) 100 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735824Vybrique (as sildenafil citrate) 25 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735827Vybrique (as sildenafil citrate) 50 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88
2735831Vybrique (as sildenafil citrate) 75 MG Oral FilmSY9213fec1-e0c0-4ef7-9718-d97922a3f4d88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71858-0205-2718580205021 FILM in 1 POUCH (71858-0205-2) 1 film2026-02-15YesNoHistorical
71858-0205-4718580205041 FILM in 1 POUCH (71858-0205-4) 1 film2026-02-15NoNoHistorical
71858-0205-5718580205054 POUCH in 1 CARTON (71858-0205-5) / 1 FILM in 1 POUCH4 pouch2026-02-15NoNoHistorical
71858-0205-6718580205068 POUCH in 1 CARTON (71858-0205-6) / 1 FILM in 1 POUCH8 pouch2026-02-15NoNoHistorical