Vybrique

Product NDC: 71858-0210
Requested package NDC: 71858-0210-2
11-digit product format: 718580210
Labeler code: 71858
Product ID: 71858-0210_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: 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210858-001	VYBRIQUE	SILDENAFIL CITRATE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-002	VYBRIQUE	SILDENAFIL CITRATE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-003	VYBRIQUE	SILDENAFIL CITRATE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16
N210858-004	VYBRIQUE	SILDENAFIL CITRATE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210858-001	11123287	2033-12-16	Drug product	2026-01-09
N210858-002	11123287	2033-12-16	Drug product	2026-01-09
N210858-003	11123287	2033-12-16	Drug product	2026-01-09
N210858-004	11123287	2033-12-16	Drug product	2026-01-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210858-001	NP	2028-12-16
N210858-002	NP	2028-12-16
N210858-003	NP	2028-12-16
N210858-004	NP	2028-12-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210858-001	VYBRIQUE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	VYBRIQUE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	VYBRIQUE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	VYBRIQUE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	VYBRIQUE	EQ 25MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	VYBRIQUE	EQ 50MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	VYBRIQUE	EQ 75MG BASE	FILM / ORAL	RLD	2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	VYBRIQUE	EQ 100MG BASE	FILM / ORAL	RLD, RS	2025-12-16	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210858-001	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	11123287	2033-12-16	Drug product	2026-01-09	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	11123287	2033-12-16	Drug product	2026-01-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210858-001	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-002	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-003	NP	2028-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210858-004	NP	2028-12-16	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-001	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-002	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-003	NP	2028-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210858-004	NP	2028-12-16	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Vybrique
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BW9B0ZE037	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2735815	Internal RxNorm lookup
2735821	Internal RxNorm lookup
2735822	Internal RxNorm lookup
2735824	Internal RxNorm lookup
2735825	Internal RxNorm lookup
2735827	Internal RxNorm lookup
2735829	Internal RxNorm lookup
2735831	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9213fec1-e0c0-4ef7-9718-d97922a3f4d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71858-0210-1	Vybrique	2 in 1 CARTON	FILM	2	8
71858-0210-1	Vybrique	1 in 1 POUCH	FILM	1	8
71858-0210-2	Vybrique	1 in 1 POUCH	FILM	1	8
71858-0210-4	Vybrique	1 in 1 POUCH	FILM	1	8
71858-0210-5	Vybrique	4 in 1 CARTON	FILM	4	8
71858-0210-5	Vybrique	1 in 1 POUCH	FILM	1	8
71858-0210-6	Vybrique	8 in 1 CARTON	FILM	8	8
71858-0210-6	Vybrique	1 in 1 POUCH	FILM	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71858-0210-5	EA - Each	71858-0210	45368788-8ebc-4632-8088-4da90458e356	1	2026-03-17
71858-0210-6	EA - Each	71858-0210	f03d34da-3d97-4d9c-bf8d-3e06fe89d2de	1	2026-03-17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL CITRATE	Yaral Pharma Inc.	a17a970e-25a2-4807-9644-74e6d2bd2383	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210858 application number: NDA210858
Vybrique	SILDENAFIL CITRATE	IBSA Pharma Inc.	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210858 application number: NDA210858 ndc (package): 71858-0210-2 ndc (product): 71858-0210 ndc11 (package): 71858021002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2735815	sildenafil 100 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735822	sildenafil 25 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735825	sildenafil 50 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735829	sildenafil 75 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735821	Vybrique 100 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735824	vybrique 25 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735827	vybrique 50 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735831	vybrique 75 MG Oral Film	PSN	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735821	sildenafil 100 MG Oral Film [Vybrique]	SBD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735824	sildenafil 25 MG Oral Film [Vybrique]	SBD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735827	sildenafil 50 MG Oral Film [Vybrique]	SBD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735831	sildenafil 75 MG Oral Film [Vybrique]	SBD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735815	sildenafil 100 MG Oral Film	SCD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735822	sildenafil 25 MG Oral Film	SCD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735825	sildenafil 50 MG Oral Film	SCD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735829	sildenafil 75 MG Oral Film	SCD	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735815	sildenafil (as sildenafil citrate) 100 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735822	sildenafil (as sildenafil citrate) 25 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735825	sildenafil (as sildenafil citrate) 50 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735829	sildenafil (as sildenafil citrate) 75 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735821	Vybrique (as sildenafil citrate) 100 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735824	Vybrique (as sildenafil citrate) 25 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735827	Vybrique (as sildenafil citrate) 50 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8
2735831	Vybrique (as sildenafil citrate) 75 MG Oral Film	SY	9213fec1-e0c0-4ef7-9718-d97922a3f4d8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71858-0210-2	71858021002	1 FILM in 1 POUCH (71858-0210-2)	1 film	2026-02-15	Yes	No	Current