Home NDC 27505-003-67 Revonto
Product NDC 27505-003
Requested package NDC 27505-003-67
11-digit product format 275050003
Labeler code 27505
Product ID 27505-003_cfcfad0f-e5e4-bfd6-e053-2995a90a0cef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dantrolene sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler US WorldMeds, LLC
Application ANDA078378
Marketing category ANDA
Marketing start 2012-06-04
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded dantrolene sodium ACTIVE INGREDIENT 287M0347EV REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [US WORLDMEDS, LLC] 2 dantrolene ACTIVE MOIETY F64QU97QCR REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [US WORLDMEDS, LLC] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [US WORLDMEDS, LLC] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [US WORLDMEDS, LLC] 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 27505-003-67 27505000367 6 VIAL, GLASS in 1 CARTON (27505-003-67) > 60 mL in 1 VIAL, GLASS 2012-06-04 0000-00-00 No No Current