Prescription drug · ANDA
Dantrolene Sodium NDC 72162-2045
Dantrolene sodium 25 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2045-1 | 72162204501 | 100 CAPSULE in 1 BOTTLE (72162-2045-1)Marketed from Jun 14, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076686
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 72162-2045_57a49e45-2998-4eda-9eac-fe843ceeb892SPL ID 57a49e45-2998-4eda-9eac-fe843ceeb892SPL set ID dbf78d48-71a6-4a9b-bf31-e710b78944f2RxCUI 856656UNII 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 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
N472162204501followed by a unit qualifier and the quantityPackage 72162-2045-01. 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 capsules are 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 capsules is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage ti…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076686
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 | Elite Laboratories, Inc. | 64850-840 |
| Dantrolene Sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-841 |
| Dantrolene Sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-842 |
| Dantrolene Sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2047 |
| Dantrolene Sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2046 |