Prescription drug · NDA
RYANODEX dantrolene sodium (Dantrolene sodium) NDC 42367-540
Dantrolene sodium 250 mg/5mL · Injection, Suspension · Intravenous · Eagle Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42367-540-32 | 4236705403242367054032 | 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIALMarketed from Jul 23, 2014 |
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)
- RYANODEX dantrolene sodiumSuffix: dantrolene sodium
- Generic name (nonproprietary)
- dantrolene sodium
- Active ingredients
- Dantrolene sodium — 250 mg/5mL
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- Eagle Pharmaceuticals, Inc.NDC labeler code 42367
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205579
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 42367-540_2489f99a-e34f-4773-be47-35ebb68cabfbSPL ID 2489f99a-e34f-4773-be47-35ebb68cabfbSPL set ID 8f7b3ac0-604d-4c78-b545-5e0f8ea3d698RxCUI 1544753, 1544758UNII 287M0347EVUPC 0342367540325
- 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
N442367054032followed by a unit qualifier and the quantityPackage 42367-0540-32. 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)
RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42367-540
- What is NDC 42367-540?
- 42367-540 is the product NDC for RYANODEX dantrolene sodium (dantrolene sodium), Dantrolene sodium 250 mg/5mL injection, suspension, listed with the FDA by Eagle Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- RYANODEX dantrolene sodium (Dantrolene sodium).
- What is the active ingredient?
- Dantrolene sodium.
- Who is the labeler?
- Eagle Pharmaceuticals, Inc., NDC labeler code 42367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for RYANODEX dantrolene sodium?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.