Home NDC 84549-003 Revonto
Product NDC 84549-003
11-digit product format 845490003
Labeler code 84549
Product ID 84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dantrolene sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application ANDA078378
Marketing category ANDA
Marketing start 2021-04-09
Substance DANTROLENE SODIUM
Active strength 20 mg/60mL
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 A078378-001 REVONTO DANTROLENE SODIUM 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078378-001 AP
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 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078378-001 REVONTO 20MG/VIAL INJECTABLE / INJECTION AP 2007-07-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Revonto
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DANTROLENE SODIUM 20 mg/60mL
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 856696 Internal RxNorm lookup 1012465 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 84549-003-67 Revonto 60 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 60 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84549-003-67 84549000367 60 mL in 1 VIAL, GLASS (84549-003-67) 60 ml 2025-09-15 No No Current