Home NDC 60923-227 AMONDYS 45
Product NDC 60923-227
11-digit product format 609230227
Labeler code 60923
Product ID 60923-227_f388df1b-13aa-4b95-a7fa-9694dc86981c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name casimersen
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sarepta Therapeutics, Inc.
Application NDA213026
Marketing category NDA
Marketing start 2021-02-25
Substance CASIMERSEN
Active strength 50 mg/mL
Pharmacologic classes Antisense Oligonucleotide [EPC], Increased Protein Synthesis [PE], 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213026-001 AMONDYS 45 CASIMERSEN 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 N213026-001 9758783 2030-11-12 U-3089 2021-03-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213026-001 NCE 2026-02-25 N213026-001 ODE-347 2028-02-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213026-001 AMONDYS 45 100MG/2ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-02-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 288 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213026-001 9758783 2030-11-12 U-3089 2021-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213026-001 9758783 2030-11-12 U-3089 2021-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213026-001 9758783 2030-11-12 U-3089 2021-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 9447415 2025-06-28 Drug substance, Drug product 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213026-001 9758783 2030-11-12 U-3089 2021-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213026-001 9447415 2025-06-28 Drug substance, Drug product 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 RE48960 2029-02-16 U-3087 Drug substance, Drug product 2022-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 RE48960 2029-02-16 U-3088 Drug substance, Drug product 2022-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 10287586 2030-11-12 Drug substance, Drug product 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 10781450 2030-11-12 U-3089 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 9228187 2030-11-12 Drug substance, Drug product 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 9758783 2030-11-12 U-3088 2021-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213026-001 9758783 2030-11-12 U-3089 2021-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213026-001 9447415 2025-06-28 Drug substance, Drug product 2021-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213026-001 RE48960 2025-06-28 U-3087 Drug substance, Drug product 2022-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213026-001 RE48960 2025-06-28 U-3088 Drug substance, Drug product 2022-03-31 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 71 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AMONDYS 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CASIMERSEN 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X8UHF7SX0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2480100 Internal RxNorm lookup 2480105 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 60923-227-02 AMONDYS 45 2 mL in 1 VIAL, SINGLE-USE INJECTION 2 11 60923-227-02 AMONDYS 45 1 in 1 CARTON INJECTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60923-227 AMONDYS 45 (CASIMERSEN) INJECTION [SAREPTA THERAPEUTICS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250321_e9e5fd44-eeda-4580-bba1-a734828bbcc3.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 Marketing start Marketing end Sample Exclude flag Status 60923-227-02 60923022702 1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) / 2 mL in 1 VIAL, SINGLE-USE 2021-02-25 0000-00-00 No No Current