Home NDC 42367-540-32 RYANODEX
Product NDC 42367-540
Requested package NDC 42367-540-32
11-digit product format 423670540
Labeler code 42367
Product ID 42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dantrolene sodium
Dosage form INJECTION, SUSPENSION
Route INTRAVENOUS
Labeler Eagle Pharmaceuticals, Inc.
Application NDA205579
Marketing category NDA
Marketing start 2014-07-23
Substance DANTROLENE SODIUM
Active strength 250 mg/5mL
Pharmacologic classes Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205579-001 RYANODEX DANTROLENE SODIUM 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22
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 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205579-001 RYANODEX 250MG/VIAL FOR SUSPENSION / INTRAVENOUS RLD, RS 2014-07-22 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 117 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205579-001 7758890 2025-06-30 Drug product 2014-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 8604072 2022-12-24 Drug product 2014-07-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 8685460 2023-02-15 U-1546 2014-08-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205579-001 7758890 2025-07-01 Drug product 2014-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205579-001 8604072 2022-12-24 Drug product 2014-07-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205579-001 8685460 2023-02-15 U-1546 2014-08-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205579-001 7758890 2025-07-01 Drug product 2014-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205579-001 8604072 2022-12-24 Drug product 2014-07-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205579-001 8685460 2023-02-15 U-1546 2014-08-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205579-001 7758890 2025-07-01 Drug product 2014-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205579-001 8604072 2022-12-24 Drug product 2014-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205579-001 8685460 2023-02-15 U-1546 2014-08-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205579-001 7758890 2025-07-01 Drug product 2014-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205579-001 8604072 2022-12-24 Drug product 2014-07-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205579-001 8685460 2023-02-15 U-1546 2014-08-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205579-001 7758890 2025-07-01 Drug product 2014-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205579-001 9884044 2022-06-13 U-1546 Drug product 2018-02-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205579-001 8110225 2022-12-24 Drug product 2014-07-28 782e0a99824c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base RYANODEX
Brand name suffix dantrolene sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DANTROLENE SODIUM 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 287M0347EV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1544753 Internal RxNorm lookup 1544758 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 42367-540-32 RYANODEX dantrolene sodium 1 in 1 CARTON INJECTION, SUSPENSION 1 10 42367-540-32 RYANODEX dantrolene sodium 20 mL in 1 VIAL INJECTION, SUSPENSION 20 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded dantrolene sodium ACTIVE INGREDIENT 287M0347EV RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 dantrolene ACTIVE MOIETY F64QU97QCR RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 nitrogen INACTIVE INGREDIENT N762921K75 RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 povidone k12 INACTIVE INGREDIENT 333AG72FWJ RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42367-540 RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) INJECTION, SUSPENSION [EAGLE PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241101_8f7b3ac0-604d-4c78-b545-5e0f8ea3d698.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 Units Marketing start Marketing end Sample Exclude flag Status 42367-540-32 42367054032 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL 1 vial 2014-07-23 0000-00-00 No No Current