Prescription drug · ANDA
Revonto (Dantrolene sodium) NDC 78670-003
Dantrolene sodium 20 mg/60mL · Injection, Powder, Lyophilized, For solution · Intravenous · USWM, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78670-003-67 | 7867000036778670000367 | 6 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASSMarketed from Apr 9, 2021 |
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
- USWM, LLCNDC labeler code 78670
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078378
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 78670-003_e2a8cdae-f253-4b7a-b9ab-c66506106aefSPL ID e2a8cdae-f253-4b7a-b9ab-c66506106aefSPL set ID f1650487-32bd-4017-b9c2-b38829a531afRxCUI 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.
- NDC on a medical claim
N478670000367followed by a unit qualifier and the quantityPackage 78670-0003-67. 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 .
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.
About NDC 78670-003
- What is NDC 78670-003?
- 78670-003 is the product NDC for Revonto (dantrolene sodium), Dantrolene sodium 20 mg/60mL injection, powder, lyophilized, for solution, listed with the FDA by USWM, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Revonto (Dantrolene sodium).
- What is the active ingredient?
- Dantrolene sodium.
- Who is the labeler?
- USWM, LLC, NDC labeler code 78670. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Revonto?
- 1 other product NDC are listed under this name. See all Revonto NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Revonto products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Revontodantrolene sodium | Dantrolene sodium 20 mg/60mL | Injection, Powder, Lyophilized, For solutionIntravenous | ProPharma Distribution | 84549-003 | 84549-0003-67 |
Other NDCs under ANDA 078378
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Revontodantrolene sodium | Dantrolene sodium 20 mg/60mL | Injection, Powder, Lyophilized, For solutionIntravenous | ProPharma Distribution | 84549-003 |