FDA.reportPublic FDA data

QALSODY

Product NDC
64406-109
11-digit product format
644060109
Labeler code
64406
Product ID
64406-109_cd6631f3-a134-4743-81b1-ede10394e394
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
2026-12-31
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-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
2026-02-19 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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001106695462035-04-01U-35752023-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215887-001109684532035-04-01U-35752023-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001103853412035-04-01Drug substance, Drug product2023-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001106695462035-04-01U-35752023-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215887-001109684532035-04-01U-35752023-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001103853412035-04-01Drug substance, Drug product2023-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001106695462035-04-01U-35752023-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215887-001109684532035-04-01U-35752023-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215887-001103853412035-04-01Drug substance, Drug product2023-05-188072bd15b7f6…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
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…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215887-001NCE2028-04-25a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N215887-001ODE-4322030-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215887-001NCE2028-04-259b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N215887-001ODE-4322030-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215887-001NCE2028-04-25a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N215887-001ODE-4322030-04-25a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
QALSODY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOFERSEN100 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2NU6F9601KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2634999Internal RxNorm lookup
2635005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81356b45-1cb7-4eef-88ea-e44cc18b47c5Available on FDA.report

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QALSODYTOFERSENBiogen Inc.81356b45-1cb7-4eef-88ea-e44cc18b47c52024-11-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 215887
application number: NDA215887
ndc (product): 64406-109

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