Home NDC 64406-031-01 ZURZUVAE
Product NDC 64406-031
Requested package NDC 64406-031-01
11-digit product format 644060031
Labeler code 64406
Product ID 64406-031_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 30 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 42 .
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 TE codes 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.
Product history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-002 ZURZUVAE 25MG CAPSULE / ORAL RLD 2023-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217369-003 ZURZUVAE 30MG CAPSULE / ORAL RLD, RS 2023-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217369-001 ZURZUVAE 20MG CAPSULE / ORAL RLD 2023-10-31 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 7 · 279 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 10172871 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 10342810 2034-04-17 U-2552 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 11236121 2037-08-23 Drug substance 2023-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217369-003 11884696 2037-08-23 U-2552 2024-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 10172871 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 10342810 2034-04-17 U-2552 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 11236121 2037-08-23 Drug substance 2023-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217369-003 11884696 2037-08-23 U-2552 2024-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 10172871 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 10342810 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 11236121 2037-08-23 Drug substance 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-001 11884696 2037-08-23 U-2552 2024-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 10172871 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 10342810 2034-04-17 U-2552 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 9512165 2034-04-17 Drug substance, Drug product 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 11236121 2037-08-23 Drug substance 2023-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217369-002 11884696 2037-08-23 U-2552 2024-02-26 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZURZUVAE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZURANOLONE 30 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64406-031-01 ZURZUVAE 14 in 1 BOTTLE CAPSULE 14 17 64406-031-01 ZURZUVAE 1 in 1 CARTON CAPSULE 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64406-031 ZURZUVAE (ZURANOLONE) CAPSULE [BIOGEN MA INC.] 14 Current NDC, 2 package rows 20241120_f18e53b0-d0bb-422d-8de7-ab64b7292b29.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64406-031-01 64406003101 1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLE 1 bottle 2023-10-31 No No Current