Vyalev

Product NDC: 0074-0501
11-digit product format: 000740501
Labeler code: 0074
Product ID: 0074-0501_1f0fe652-c027-4b61-9ba4-78548dd48e89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: foscarbidopa/foslevodopa
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: AbbVie Inc.
Application: NDA216962
Marketing category: NDA
Marketing start: 2022-04-12
Substance: FOSCARBIDOPA; FOSLEVODOPA
Active strength: 12; 240 mg/mL; mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216962-001	VYALEV	FOSCARBIDOPA; FOSLEVODOPA	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-10-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14
N216962-001	10730895	2035-10-21		Drug substance	2024-11-14
N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14
N216962-001	12251365	2040-06-10	U-4030		2025-04-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216962-001	NP	2027-10-16

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	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	VYALEV	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-10-16	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216962-001	12251365	2040-06-10	U-4030		2025-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	12251365	2040-06-10	U-4030		2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216962-001	12251365	2040-06-10	U-4030		2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	10174061	2035-10-21	U-4030	Drug product	2024-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	10730895	2035-10-21		Drug substance	2024-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	9446059	2035-10-21	U-4030	Drug substance, Drug product	2024-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	12251365	2040-06-10	U-4030		2025-04-10	`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	N216962-001	NP	2027-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216962-001	NP	2027-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216962-001	NP	2027-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216962-001	NP	2027-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216962-001	NP	2027-10-16	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216962-001	NP	2027-10-16	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSCARBIDOPA	12 mg/mL
FOSLEVODOPA	240 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5NT8HCA4OO	Internal UNII lookup
37NQZ0J76I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2695782	Internal RxNorm lookup
2695789	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
28e806e4-951c-40a9-9f0c-d0929caf054c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
162160fe-5ea6-4f9d-aa38-c4b780c57046	Product name	1	20250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0074-0501-01	Vyalev	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		6
0074-0501-01	Vyalev	7 in 1 CARTON	INJECTION	7		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-0501-01	ML - Milliliter	0074-0501	d13a873c-3fc6-465f-8b2a-80050723bc3f	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-0501	VYALEV (FOSCARBIDOPA/FOSLEVODOPA) INJECTION [ABBVIE INC.]	4	Current NDC, 2 package rows	20241024_28e806e4-951c-40a9-9f0c-d0929caf054c.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vyalev	FOSCARBIDOPA/FOSLEVODOPA	AbbVie Inc.	28e806e4-951c-40a9-9f0c-d0929caf054c	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216962 application number: NDA216962 ndc (product): 0074-0501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5NT8HCA4OO	FOSCARBIDOPA	1907685-81-7	FOSCARBIDOPA
37NQZ0J76I	FOSLEVODOPA	97321-87-4	FOSLEVODOPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2695782	foscarbidopa 120 MG / foslevodopa 2400 MG in 10 ML Injection	PSN	28e806e4-951c-40a9-9f0c-d0929caf054c	6
2695789	VYALEV 120 MG / 2400 MG in 10 ML Injection	PSN	28e806e4-951c-40a9-9f0c-d0929caf054c	6
2695789	10 ML foscarbidopa 12 MG/ML / foslevodopa 240 MG/ML Injection [Vyalev]	SBD	28e806e4-951c-40a9-9f0c-d0929caf054c	6
2695782	10 ML foscarbidopa 12 MG/ML / foslevodopa 240 MG/ML Injection	SCD	28e806e4-951c-40a9-9f0c-d0929caf054c	6
2695782	foscarbidopa 120 MG / foslevodopa 2400 MG per 10 ML Injection	SY	28e806e4-951c-40a9-9f0c-d0929caf054c	6
2695789	Vyalev (foscarbidopa 120 MG / foslevodopa 2400 MG per 10 ML) Injection	SY	28e806e4-951c-40a9-9f0c-d0929caf054c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0074-0501-01	00074050101	7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-04-12	No	No	Current