FDA.reportPublic FDA data

Revonto

Product NDC
78670-003
11-digit product format
786700003
Labeler code
78670
Product ID
78670-003_e2a8cdae-f253-4b7a-b9ab-c66506106aef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dantrolene sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
USWM, LLC
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

Additional Listing Data#

Finished product
Yes
Brand name base
Revonto
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANTROLENE SODIUM20 mg/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii287M0347EV
Rxcui856696, 1012465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10Product name220170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9fProduct name220141210
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78670-003-67Revonto6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,62
78670-003-67Revonto60 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78670-003-67EA - Each78670-0032a789003-0677-4816-9a5f-35571fd1423712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78670-003REVONTO (DANTROLENE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [USWM, LLC]2Current NDC, Legacy NDC, 2 package rows20240526_f1650487-32bd-4017-b9c2-b38829a531af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856696dantrolene sodium 0.333 MG/ML Injectable SolutionPSN3edcfad5-00ad-7587-e063-6394a90addf32
856696dantrolene sodium 0.333 MG/ML Injectable SolutionPSNf1650487-32bd-4017-b9c2-b38829a531af2
1012465Revonto 0.333 MG/ML Injectable SolutionPSN3edcfad5-00ad-7587-e063-6394a90addf32
1012465Revonto 0.333 MG/ML Injectable SolutionPSNf1650487-32bd-4017-b9c2-b38829a531af2
1012465dantrolene sodium 0.333 MG/ML Injectable Solution [Revonto]SBD3edcfad5-00ad-7587-e063-6394a90addf32
1012465dantrolene sodium 0.333 MG/ML Injectable Solution [Revonto]SBDf1650487-32bd-4017-b9c2-b38829a531af2
856696dantrolene sodium 0.333 MG/ML Injectable SolutionSCD3edcfad5-00ad-7587-e063-6394a90addf32
856696dantrolene sodium 0.333 MG/ML Injectable SolutionSCDf1650487-32bd-4017-b9c2-b38829a531af2
1012465Revonto 0.333 MG/ML Injectable SolutionSY3edcfad5-00ad-7587-e063-6394a90addf32
1012465Revonto 0.333 MG/ML Injectable SolutionSYf1650487-32bd-4017-b9c2-b38829a531af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78670-003-67786700003676 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASS2021-04-090000-00-00NoNoCurrent