FDA.reportPublic FDA data

Vyondys 53

Product NDC
60923-465
11-digit product format
609230465
Labeler code
60923
Product ID
60923-465_5fbaac76-f7cb-4f43-99f8-af43c2655ff0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
golodirsen
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sarepta Therapeutics, Inc.
Application
NDA211970
Marketing category
NDA
Marketing start
2019-12-12
Substance
GOLODIRSEN
Active strength
50 mg/mL
Pharmacologic classes
Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], 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 43.

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
N211970-001VYONDYS 53GOLODIRSEN100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211970-001RE476912028-06-28Drug product2019-12-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N211970-001ODE-2802026-12-12

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
2026-09-14 22:38:342026-08N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-1284e616aacf4f…
2026-08-18 06:07:402026-07N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-124b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211970-001VYONDYS 53100MG/2ML (50MG/ML)SOLUTION / INTRAVENOUSRLD, RS2019-12-12a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 8 · 286 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N211970-001RE476912028-06-28Drug product2019-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N211970-001RE476912028-06-28Drug product2019-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211970-001RE476912028-06-28Drug product2019-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001102275902025-06-28Drug substance, Drug product2019-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001102668272025-06-28U-26752019-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001104219662025-06-28Drug substance, Drug product2019-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001109684502025-06-28Drug substance, Drug product2021-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001109953372025-06-28U-2675Drug product2021-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-00190240072025-06-28Drug substance, Drug product2019-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-00199948512025-06-28Drug substance, Drug product2019-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001RE476912028-06-28Drug product2019-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211970-001102275902025-06-28Drug substance, Drug product2019-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-001102668272025-06-28U-26752019-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-001104219662025-06-28Drug substance, Drug product2019-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-001109684502025-06-28Drug substance, Drug product2021-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-001109953372025-06-28U-2675Drug product2021-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-00190240072025-06-28Drug substance, Drug product2019-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-00199948512025-06-28Drug substance, Drug product2019-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211970-001RE476912028-06-28Drug product2019-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001102275902025-06-28Drug substance, Drug product2019-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001102668272025-06-28U-26752019-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001104219662025-06-28Drug substance, Drug product2019-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001109684502025-06-28Drug substance, Drug product2021-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001109953372025-06-28U-2675Drug product2021-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-00190240072025-06-28Drug substance, Drug product2019-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-00199948512025-06-28Drug substance, Drug product2019-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001RE476912028-06-28Drug product2019-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001102275902025-06-28Drug substance, Drug product2019-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001102668272025-06-28U-26752019-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001104219662025-06-28Drug substance, Drug product2019-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001109684502025-06-28Drug substance, Drug product2021-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001109953372025-06-28U-2675Drug product2021-06-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-00190240072025-06-28Drug substance, Drug product2019-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-00199948512025-06-28Drug substance, Drug product2019-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001RE476912028-06-28Drug product2019-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001102275902025-06-28Drug substance, Drug product2019-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001102668272025-06-28U-26752019-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001104219662025-06-28Drug substance, Drug product2019-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001109684502025-06-28Drug substance, Drug product2021-06-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001109953372025-06-28U-2675Drug product2021-06-0103ed91905a0d…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N211970-001ODE-2802026-12-1284e616aacf4f…
2026-08-18 06:07:402026-07N211970-001ODE-2802026-12-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211970-001ODE-2802026-12-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211970-001ODE-2802026-12-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N211970-001ODE-2802026-12-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211970-001ODE-2802026-12-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211970-001ODE-2802026-12-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001NCE2024-12-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211970-001ODE-2802026-12-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211970-001NCE2024-12-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211970-001ODE-2802026-12-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211970-001NCE2024-12-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211970-001ODE-2802026-12-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211970-001NCE2024-12-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211970-001ODE-2802026-12-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211970-001NCE2024-12-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N211970-001ODE-2802026-12-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211970-001NCE2024-12-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211970-001ODE-2802026-12-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211970-001NCE2024-12-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211970-001ODE-2802026-12-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211970-001NCE2024-12-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211970-001ODE-2802026-12-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211970-001NCE2024-12-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211970-001ODE-2802026-12-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211970-001NCE2024-12-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211970-001ODE-2802026-12-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211970-001NCE2024-12-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N211970-001ODE-2802026-12-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211970-001NCE2024-12-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N211970-001ODE-2802026-12-124b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211970-001NCE2024-12-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N211970-001ODE-2802026-12-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211970-001NCE2024-12-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N211970-001ODE-2802026-12-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211970-001NCE2024-12-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N211970-001ODE-2802026-12-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N211970-001NCE2024-12-125aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N211970-001ODE-2802026-12-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N211970-001NCE2024-12-128869cabd3fbd…

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
Vyondys 53
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLODIRSEN50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
033072U4MZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2267211Internal RxNorm lookup
2267216Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
35cc3095-9602-450f-8b18-327bc703b2b2Product name120200603
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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
60923-465-02Vyondys 532 mL in 1 VIAL, SINGLE-USEINJECTION216
60923-465-02Vyondys 531 in 1 CARTONINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60923-465-02ML - Milliliter60923-46544470389-22fe-4675-92e8-a96113ff4d9812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60923-465VYONDYS 53 (GOLODIRSEN) INJECTION [SAREPTA THERAPEUTICS, INC.]15Current NDC, Legacy NDC, 2 package rows20250321_35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5.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
Vyondys 53GOLODIRSENSarepta Therapeutics, Inc.35c227d1-5b24-44b0-b5d3-f0f6b1c46bd52025-03-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 211970
application number: NDA211970
ndc (product): 60923-465

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2267211golodirsen 100 MG in 2 ML InjectionPSN35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
2267216VYONDYS 53 Injection 100 MG in 2 MLPSN35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
22672162 ML golodirsen 50 MG/ML Injection [Vyondys 53]SBD35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
22672112 ML golodirsen 50 MG/ML InjectionSCD35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
22672162 ML Vyondys 53 50 MG/ML InjectionSY35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
2267211golodirsen 100 MG per 2 ML InjectionSY35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516
2267216VYONDYS 53 Injection 100 MG per 2 MLSY35c227d1-5b24-44b0-b5d3-f0f6b1c46bd516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60923-465-02609230465021 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) / 2 mL in 1 VIAL, SINGLE-USE2019-12-120000-00-00NoNoCurrent