FDA.reportPublic FDA data

QALSODY

Product NDC
64406-109
11-digit product format
644060109
Labeler code
64406
Product ID
64406-109_fd8c8926-bd3e-49ef-94a1-8a964edc078a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tofersen
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Biogen Inc.
Application
NDA215887
Marketing category
NDA
Marketing start
2023-04-25
Substance
TOFERSEN
Active strength
100 mg/15mL
Pharmacologic classes
Antisense Oligonucleotide [EPC], Oligonucleotides, Antisense [CS]
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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215887-001QALSODYTOFERSEN100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215887-001103853412035-04-01Drug substance, Drug product2023-05-18
N215887-001106695462035-04-01U-35752023-05-18
N215887-001109684532035-04-01U-35752023-05-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215887-001NCE2028-04-25
N215887-001ODE-4322030-04-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25c2088c7a36db…
2026-09-14 22:38:342026-08N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-2584e616aacf4f…
2026-08-18 06:07:402026-07N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-253f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215887-001QALSODY100MG/15ML (6.7MG/ML)SOLUTION / INTRATHECALRLD, RS2023-04-25a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N215887-001103853412035-04-01Drug substance, Drug product2023-05-18c2088c7a36db…
2026-10-15 13:18:302026-09N215887-001106695462035-04-01U-35752023-05-18c2088c7a36db…
2026-10-15 13:18:302026-09N215887-001109684532035-04-01U-35752023-05-18c2088c7a36db…
2026-09-14 22:38:342026-08N215887-001103853412035-04-01Drug substance, Drug product2023-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N215887-001106695462035-04-01U-35752023-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N215887-001109684532035-04-01U-35752023-05-1884e616aacf4f…
2026-08-18 06:07:402026-07N215887-001103853412035-04-01Drug substance, Drug product2023-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N215887-001106695462035-04-01U-35752023-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N215887-001109684532035-04-01U-35752023-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215887-001103853412035-04-01Drug substance, Drug product2023-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215887-001106695462035-04-01U-35752023-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215887-001109684532035-04-01U-35752023-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001103853412035-04-01Drug substance, Drug product2023-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001106695462035-04-01U-35752023-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001109684532035-04-01U-35752023-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215887-001103853412035-04-01Drug substance, Drug product2023-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215887-001106695462035-04-01U-35752023-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215887-001109684532035-04-01U-35752023-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001103853412035-04-01Drug substance, Drug product2023-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001106695462035-04-01U-35752023-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001109684532035-04-01U-35752023-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001103853412035-04-01Drug substance, Drug product2023-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001106695462035-04-01U-35752023-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001109684532035-04-01U-35752023-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001103853412035-04-01Drug substance, Drug product2023-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001106695462035-04-01U-35752023-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001109684532035-04-01U-35752023-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001103853412035-04-01Drug substance, Drug product2023-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001106695462035-04-01U-35752023-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001109684532035-04-01U-35752023-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001103853412035-04-01Drug substance, Drug product2023-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001106695462035-04-01U-35752023-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001109684532035-04-01U-35752023-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001103853412035-04-01Drug substance, Drug product2023-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001106695462035-04-01U-35752023-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001109684532035-04-01U-35752023-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215887-001103853412035-04-01Drug substance, Drug product2023-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N215887-001106695462035-04-01U-35752023-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N215887-001109684532035-04-01U-35752023-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001103853412035-04-01Drug substance, Drug product2023-05-1879d66fd596c7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N215887-001NCE2028-04-25c2088c7a36db…
2026-10-15 13:18:302026-09N215887-001ODE-4322030-04-25c2088c7a36db…
2026-09-14 22:38:342026-08N215887-001NCE2028-04-2584e616aacf4f…
2026-09-14 22:38:342026-08N215887-001ODE-4322030-04-2584e616aacf4f…
2026-08-18 06:07:402026-07N215887-001NCE2028-04-25caaa826d4ba7…
2026-08-18 06:07:402026-07N215887-001ODE-4322030-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215887-001NCE2028-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215887-001ODE-4322030-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001NCE2028-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215887-001ODE-4322030-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N215887-001NCE2028-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215887-001ODE-4322030-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001NCE2028-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215887-001ODE-4322030-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001NCE2028-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215887-001ODE-4322030-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001NCE2028-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215887-001ODE-4322030-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001NCE2028-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215887-001ODE-4322030-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001NCE2028-04-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215887-001ODE-4322030-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001NCE2028-04-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215887-001ODE-4322030-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215887-001NCE2028-04-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N215887-001ODE-4322030-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001NCE2028-04-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001ODE-4322030-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001NCE2028-04-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001ODE-4322030-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001NCE2028-04-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001ODE-4322030-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215887-001NCE2028-04-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N215887-001ODE-4322030-04-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215887-001NCE2028-04-256a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215887-001ODE-4322030-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215887-001NCE2028-04-251c564ffb4f44…
2024-02-18 07:12 UTC2024-02N215887-001ODE-4322030-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N215887-001NCE2028-04-25ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N215887-001ODE-4322030-04-25ea1830bbd6c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFERSEN100 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
1dff1054-fcf3-4c05-b834-fe7d040b9125Product name120230606
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64406-109-01QALSODY15 mL in 1 VIAL, SINGLE-USEINJECTION153
64406-109-01QALSODY1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-109-01ML - Milliliter64406-1093030d524-15fb-44d9-89c6-d87499b29f4e12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-109QALSODY (TOFERSEN) INJECTION [BIOGEN INC.]3Current NDC, 2 package rows20241116_81356b45-1cb7-4eef-88ea-e44cc18b47c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2635005QALSODY 100 MG in 15 ML InjectionPSN81356b45-1cb7-4eef-88ea-e44cc18b47c53
2634999tofersen 100 MG in 15 ML InjectionPSN81356b45-1cb7-4eef-88ea-e44cc18b47c53
263500515 ML tofersen 6.7 MG/ML Injection [Qalsody]SBD81356b45-1cb7-4eef-88ea-e44cc18b47c53
263499915 ML tofersen 6.7 MG/ML InjectionSCD81356b45-1cb7-4eef-88ea-e44cc18b47c53
2635005Qalsody 100 MG per 15 ML InjectionSY81356b45-1cb7-4eef-88ea-e44cc18b47c53
2635005Qalsody 6.7 MG/ML per 15 ML InjectionSY81356b45-1cb7-4eef-88ea-e44cc18b47c53
2634999tofersen 100 MG per 15 ML InjectionSY81356b45-1cb7-4eef-88ea-e44cc18b47c53
2634999tofersen 6.7 MG/ML per 15 ML InjectionSY81356b45-1cb7-4eef-88ea-e44cc18b47c53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64406-109-01644060109011 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE2023-04-25NoNoCurrent