ZURZUVAE

Product NDC: 64406-029
11-digit product format: 644060029
Labeler code: 64406
Product ID: 64406-029_c77b27a2-3351-4ec4-831c-98e20df89225
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zuranolone
Dosage form: CAPSULE
Route: ORAL
Labeler: Biogen MA Inc.
Application: NDA217369
Marketing category: NDA
Marketing start: 2023-10-31
Substance: ZURANOLONE
Active strength: 20 mg/1
Pharmacologic classes: GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule: CIV
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N217369-001	ZURZUVAE	ZURANOLONE	20MG	CAPSULE / ORAL	RLD	2023-10-31
N217369-002	ZURZUVAE	ZURANOLONE	25MG	CAPSULE / ORAL	RLD	2023-10-31
N217369-003	ZURZUVAE	ZURANOLONE	30MG	CAPSULE / ORAL	RLD, RS	2023-10-31

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217369-001	10172871	2034-04-17	U-2552		2023-11-27
N217369-001	10342810	2034-04-17	U-2552		2023-11-27
N217369-001	9512165	2034-04-17		Drug substance, Drug product	2023-11-27
N217369-001	11236121	2037-08-23		Drug substance	2023-11-27
N217369-001	11884696	2037-08-23	U-2552		2024-02-26
N217369-002	10172871	2034-04-17	U-2552		2023-11-27
N217369-002	10342810	2034-04-17	U-2552		2023-11-27
N217369-002	9512165	2034-04-17		Drug substance, Drug product	2023-11-27
N217369-002	11236121	2037-08-23		Drug substance	2023-11-27
N217369-002	11884696	2037-08-23	U-2552		2024-02-26
N217369-003	10172871	2034-04-17	U-2552		2023-11-27
N217369-003	10342810	2034-04-17	U-2552		2023-11-27
N217369-003	9512165	2034-04-17		Drug substance, Drug product	2023-11-27
N217369-003	11236121	2037-08-23		Drug substance	2023-11-27
N217369-003	11884696	2037-08-23	U-2552		2024-02-26

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217369-001	NCE	2028-10-31
N217369-002	NCE	2028-10-31
N217369-003	NCE	2028-10-31

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
2026-08-01 22:54:32	2026-06	N217369-001	ZURZUVAE	20MG	CAPSULE / ORAL	RLD	2023-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	ZURZUVAE	25MG	CAPSULE / ORAL	RLD	2023-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	ZURZUVAE	30MG	CAPSULE / ORAL	RLD, RS	2023-10-31	`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
2026-08-01 22:54:32	2026-06	N217369-001	10172871	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-001	10342810	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-001	9512165	2034-04-17		Drug substance, Drug product	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-001	11236121	2037-08-23		Drug substance	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-001	11884696	2037-08-23	U-2552		2024-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	10172871	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	10342810	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	9512165	2034-04-17		Drug substance, Drug product	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	11236121	2037-08-23		Drug substance	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	11884696	2037-08-23	U-2552		2024-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	10172871	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	10342810	2034-04-17	U-2552		2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	9512165	2034-04-17		Drug substance, Drug product	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	11236121	2037-08-23		Drug substance	2023-11-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	11884696	2037-08-23	U-2552		2024-02-26	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N217369-001	NCE	2028-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-002	NCE	2028-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217369-003	NCE	2028-10-31	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ZURZUVAE	ZURANOLONE	Biogen MA Inc.	f18e53b0-d0bb-422d-8de7-ab64b7292b29	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217369 application number: NDA217369 ndc (product): 64406-029

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZURANOLONE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7ZW49N180B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2669910	Internal RxNorm lookup
2669916	Internal RxNorm lookup
2669918	Internal RxNorm lookup
2669920	Internal RxNorm lookup
2669922	Internal RxNorm lookup
2669924	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
f18e53b0-d0bb-422d-8de7-ab64b7292b29	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
678bbbae-d295-47ce-b5bc-5810bfcf0b29	Product name	1	20231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64406-029-01	ZURZUVAE	14 in 1 BOTTLE	CAPSULE	14		17
64406-029-01	ZURZUVAE	1 in 1 CARTON	CAPSULE	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-029-01	EA - Each	64406-029	553f6f63-bfef-4dbc-b46b-cffae81c95a0	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-029	ZURZUVAE (ZURANOLONE) CAPSULE [BIOGEN MA INC.]	14	Current NDC, 2 package rows	20241120_f18e53b0-d0bb-422d-8de7-ab64b7292b29.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7ZW49N180B	ZURANOLONE	1632051-40-1	ZURANOLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2669910	zuranolone 20 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669918	zuranolone 25 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669922	zuranolone 30 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669916	ZURZUVAE 20 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669920	ZURZUVAE 25 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669924	ZURZUVAE 30 MG Oral Capsule	PSN	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669916	zuranolone 20 MG Oral Capsule [Zurzuvae]	SBD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669920	zuranolone 25 MG Oral Capsule [Zurzuvae]	SBD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669924	zuranolone 30 MG Oral Capsule [Zurzuvae]	SBD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669910	zuranolone 20 MG Oral Capsule	SCD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669918	zuranolone 25 MG Oral Capsule	SCD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669922	zuranolone 30 MG Oral Capsule	SCD	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669916	Zurzuvae 20 MG Oral Capsule	SY	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669920	Zurzuvae 25 MG Oral Capsule	SY	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17
2669924	Zurzuvae 30 MG Oral Capsule	SY	f18e53b0-d0bb-422d-8de7-ab64b7292b29	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64406-029-01	64406002901	1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE	1 bottle	2023-10-31	No	No	Current