Revonto (dantrolene sodium) NDC 84549-003

NDC codes

FDA NDC Directory

Product NDC (as listed)84549-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84549-0003Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
84549-003-67	84549000367	60 mL in 1 VIAL, GLASS (84549-003-67)Marketed from Sep 15, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Revonto
Generic name (nonproprietary): dantrolene sodium
Active ingredients: Dantrolene sodium — 20 mg/60mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: ProPharma Distribution
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078378
Marketing start: Apr 9, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
Identifiers: Product ID 84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6SPL ID 463e554f-a0fa-ab45-e063-6294a90abcf6SPL set ID 3edcfad5-00ad-7587-e063-6394a90addf3RxCUI 856696, 1012465UNII 287M0347EV
Pharmacologic class: Skeletal Muscle Relaxant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N484549000367 followed by a unit qualifier and the quantity

Package 84549-0003-67. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 18, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). Revonto is also indicated preoperatively, and sometime…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078378

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078378
Product	Strength	Form · route	Labeler	Product NDC
Revontodantrolene sodium	Dantrolene sodium 20 mg/60mL	Injection, Powder, Lyophilized, For solutionIntravenous	USWM, LLC	78670-003