Revonto (dantrolene sodium) NDC 78670-003

NDC codes

FDA NDC Directory

Product NDC (as listed)78670-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78670-0003Add 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
78670-003-67	78670000367	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, LLC
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 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.

How CPT relates to drug billing

NDC on a medical claim

N478670000367 followed by a unit qualifier and the quantity

Package 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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	ProPharma Distribution	84549-003