Prescription drug · NDA AUTHORIZED GENERIC
dantrolene sodium NDC 49884-363
Dantrolene sodium 50 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-363-01 | 49884036301 | 100 CAPSULE in 1 BOTTLE (49884-363-01)Marketed from Mar 28, 2016 |
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)
- dantrolene sodium
- Generic name (nonproprietary)
- dantrolene sodium
- Active ingredients
- Dantrolene sodium — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017443
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 49884-363_ce31d4e7-88a5-4eca-a20e-c03e31d2b88bSPL ID ce31d4e7-88a5-4eca-a20e-c03e31d2b88bSPL set ID 11689f56-15e0-4350-b53f-ae96e5994feaRxCUI 856652, 856656, 856660UNII 287M0347EVUPC 0349884362010, 0349884363017, 0349884364014
- 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
N449884036301followed by a unit qualifier and the quantityPackage 49884-0363-01. 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: Dantrolene sodium 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. Dantrolene sodium 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 DOSAG…
Excerpt only. Read the full label for complete information.
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 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4668 |
| 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 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-362 |
| 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 | 72162-1497 |
| Dantriumdantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Par Health USA, LLC | 42023-124 |
| dantrolene sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4622 |