Spinraza

Product NDC: 64406-058
11-digit product format: 644060058
Labeler code: 64406
Product ID: 64406-058_cb572584-c0fd-42aa-b6d1-6dd8260028b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nusinersen
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: Biogen Inc.
Application: NDA209531
Marketing category: NDA
Marketing start: 2016-12-23
Substance: NUSINERSEN
Active strength: 2.4 mg/mL
Pharmacologic classes: Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], Oligonucleotides, Antisense [CS], Survival Motor Neuron-2-directed RNA Interaction [EPC]
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
N209531-001	SPINRAZA	NUSINERSEN SODIUM	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23
N209531-002	SPINRAZA	NUSINERSEN SODIUM	EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2026-03-27
N209531-003	SPINRAZA	NUSINERSEN SODIUM	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2026-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209531-001	7838657	2027-07-11		Drug substance	2017-01-23
N209531-001	9717750	2030-06-17	U-1942		2017-08-31
N209531-001	9717750	2030-06-17	U-1943		2017-08-31
N209531-001	9717750	2030-06-17	U-2093		2017-08-31
N209531-001	9717750	2030-06-17	U-2094		2017-08-31
N209531-001	8980853	2030-11-24	U-1941		2017-01-23
N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23
N209531-001	9926559	2034-01-09	U-1943		2018-04-24
N209531-001	10436802	2035-09-11	U-1941		2019-10-17
N209531-001	10436802	2035-09-11	U-1942		2019-10-17
N209531-001	10436802	2035-09-11	U-1943		2019-10-17
N209531-001	10436802	2035-09-11	U-1944		2019-10-17
N209531-001	10436802	2035-09-11	U-2093		2019-10-17
N209531-001	10436802	2035-09-11	U-2094		2019-10-17
N209531-001	12013403	2036-03-04	U-1941		2024-06-28
N209531-001	12013403	2036-03-04	U-1942		2024-06-28
N209531-001	12013403	2036-03-04	U-1943		2024-06-28
N209531-001	12013403	2036-03-04	U-1944		2024-06-28
N209531-001	12013403	2036-03-04	U-2093		2024-06-28
N209531-001	12013403	2036-03-04	U-2094		2024-06-28
N209531-002	7838657	2027-07-11		Drug substance, Drug product	2026-04-20
N209531-002	9717750	2030-06-17	U-1942		2026-04-20
N209531-002	9717750	2030-06-17	U-1943		2026-04-20
N209531-002	9717750	2030-06-17	U-2093		2026-04-20
N209531-002	9717750	2030-06-17	U-2094		2026-04-20
N209531-002	8980853	2030-11-24	U-1941		2026-04-20
N209531-002	8361977	2030-12-23		Drug substance, Drug product	2026-04-20
N209531-003	7838657	2027-07-11		Drug substance, Drug product	2026-04-20
N209531-003	9717750	2030-06-17	U-1942		2026-04-20
N209531-003	9717750	2030-06-17	U-1943		2026-04-20
N209531-003	9717750	2030-06-17	U-2093		2026-04-20
N209531-003	9717750	2030-06-17	U-2094		2026-04-20
N209531-003	8980853	2030-11-24	U-1941		2026-04-20
N209531-003	8361977	2030-12-23		Drug substance, Drug product	2026-04-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209531-002	NS	2029-03-27
N209531-003	NS	2029-03-27

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 · 43 observed 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	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 909 observed states.

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	N209531-001	7838657	2027-07-11		Drug substance	2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-1942		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-2094		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-2093		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-1943		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	8980853	2030-11-24	U-1941		2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9926559	2034-01-09	U-1943		2018-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-2094		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1943		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1941		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-2093		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1944		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1942		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1941		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1942		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1943		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1944		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-2093		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-2094		2024-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1944		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1942		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1943		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1943		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1944		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1942		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	7838657	2027-07-11		Drug substance	2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-1942		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-2094		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-2093		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-1943		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8980853	2030-11-24	U-1941		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9926559	2034-01-09	U-1943		2018-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-2094		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1943		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1941		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-2093		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1944		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1942		2019-10-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209531-001	ODE-127	2023-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209531-001	ODE-127	2023-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209531-001	ODE-127	2023-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209531-001	M-226	2021-05-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209531-001	NCE	2021-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209531-001	ODE-127	2023-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209531-001	ODE-127	2023-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209531-001	M-226	2021-05-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209531-001	NCE	2021-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209531-001	ODE-127	2023-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	M-226	2021-05-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	NCE	2021-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	ODE-127	2023-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209531-001	M-226	2021-05-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209531-001	NCE	2021-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209531-001	ODE-127	2023-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209531-001	M-226	2021-05-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209531-001	NCE	2021-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209531-001	ODE-127	2023-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209531-001	M-226	2021-05-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209531-001	NCE	2021-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209531-001	ODE-127	2023-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209531-001	M-226	2021-05-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209531-001	NCE	2021-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209531-001	ODE-127	2023-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209531-001	M-226	2021-05-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209531-001	NCE	2021-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209531-001	ODE-127	2023-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209531-001	M-226	2021-05-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209531-001	NCE	2021-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209531-001	ODE-127	2023-12-23	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209531-001	ODE-127	2023-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209531-001	ODE-127	2023-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209531-001	ODE-127	2023-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209531-001	ODE-127	2023-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209531-001	ODE-127	2023-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209531-001	ODE-127	2023-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209531-001	ODE-127	2023-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209531-001	ODE-127	2023-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209531-001	ODE-127	2023-12-23	`f41ea6bd6efb…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NUSINERSEN	2.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5Z9SP3X666	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1863560	Internal RxNorm lookup
1863565	Internal RxNorm lookup
2739995	Internal RxNorm lookup
2739998	Internal RxNorm lookup
2740001	Internal RxNorm lookup
2740004	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
dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
6b9ad45c-200b-4d29-9c1e-63b1cca972cd	Product name	1	20170316
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64406-058-01	Spinraza	1 in 1 BOX	INJECTION, SOLUTION	1		21
64406-058-01	Spinraza	5 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	5		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-058-01	ML - Milliliter	64406-058	2fd1ad39-d4a1-4f46-a58e-fa2dc60bf46d	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-058	SPINRAZA (NUSINERSEN) INJECTION, SOLUTION [BIOGEN]	19	Current NDC, Legacy NDC, 2 package rows	20240423_dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94.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
Spinraza	NUSINERSEN	Biogen Inc.	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209531 application number: NDA209531 ndc (product): 64406-058

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5Z9SP3X666	NUSINERSEN	1258984-36-9	NUSINERSEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1863560	nusinersen 12 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740001	nusinersen 28 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739995	nusinersen 50 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863565	Spinraza 12 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740004	SPINRAZA 28 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739998	SPINRAZA 50 MG in 5 ML Injection	PSN	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739998	5 ML nusinersen 10 MG/ML Injection [Spinraza]	SBD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863565	5 ML nusinersen 2.4 MG/ML Injection [Spinraza]	SBD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740004	5 ML nusinersen 5.6 MG/ML Injection [Spinraza]	SBD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739995	5 ML nusinersen 10 MG/ML Injection	SCD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863560	5 ML nusinersen 2.4 MG/ML Injection	SCD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740001	5 ML nusinersen 5.6 MG/ML Injection	SCD	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863565	5 ML Spinraza 2.4 MG/ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863560	nusinersen 12 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740001	nusinersen 28 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739995	nusinersen 50 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
1863565	Spinraza 12 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2740004	Spinraza 28 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21
2739998	Spinraza 50 MG per 5 ML Injection	SY	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-058-01	64406005801	1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE	2016-12-23	0000-00-00	No	No	Current