Prescription drug · ANDA
Dantrolene NDC 0143-9297
Dantrolene sodium 20 mg/1 · Injection, Powder, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9297-01 | 00143929701 | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)Marketed from Jun 19, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Dantrolene
- Generic name (nonproprietary)
- dantrolene
- Active ingredients
- Dantrolene sodium — 20 mg/1
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204762
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67fSPL ID 769b1f03-2d55-42b7-b29d-60fb5275a67fSPL set ID ab0efc75-0598-4f4e-91ad-6195bb2661feRxCUI 856696UNII 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
N400143929701followed by a unit qualifier and the quantityPackage 00143-9297-01. 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 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. Dantrolene Sodium for Injection 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). Dantrolene Sodium for Injection is also …
Excerpt only. Read the full label for complete information.