Prescription drug · NDA
Dantrium (Dantrolene sodium) NDC 42023-124
Dantrolene sodium 25 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42023-124-01 | 4202301240142023012401 | 100 CAPSULE in 1 BOTTLE (42023-124-01)Marketed from Aug 1, 2008 |
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)
- Dantrium
- Generic name (nonproprietary)
- dantrolene sodium
- Active ingredients
- Dantrolene sodium — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 42023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017443
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 42023-124_4bcdd632-5be8-4750-a3b6-59a2b6d8f130SPL ID 4bcdd632-5be8-4750-a3b6-59a2b6d8f130SPL set ID 57b4eec1-49e1-432c-95ae-0fe36e32d64bRxCUI 856652, 856654, 856656, 856658, 856660, 856662UNII 287M0347EVUPC 0342023126016, 0342023124012, 0342023125019
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442023012401followed by a unit qualifier and the quantityPackage 42023-0124-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE In Chronic Spasticity: Dantrium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATI…
Excerpt only. Read the full label for complete information.
About NDC 42023-124
- What is NDC 42023-124?
- 42023-124 is the product NDC for Dantrium (dantrolene sodium), Dantrolene sodium 25 mg/1 capsule, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dantrium (Dantrolene sodium).
- What is the active ingredient?
- Dantrolene sodium.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 42023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dantrium?
- 1 other product NDC are listed under this name. See all Dantrium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dantrium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dantriumdantrolene sodium | Dantrolene sodium 20 mg/60mL | InjectionIntravenous | Par Health USA, LLC | 42023-123 | 42023-0123-06 |
Other NDCs under NDA 017443
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 |
|---|---|---|---|---|
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-362 |
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-363 |
| dantrolene sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-364 |
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2168 |
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2169 |
| dantrolene sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4622 |
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4668 |
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1497 |