Prescription drug · ANDA
Dantrolene Sodium NDC 0904-7211
Dantrolene sodium 25 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7211-04 | 0090472110400904721104 | 30 BLISTER PACK in 1 CARTON (0904-7211-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Jun 20, 2022 |
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 Sodium
- Generic name (nonproprietary)
- dantrolene sodium
- Active ingredients
- Dantrolene sodium — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076856
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
- Identifiers
- Product ID 0904-7211_91a9f218-7235-4e26-9e70-bd4110c3b757SPL ID 91a9f218-7235-4e26-9e70-bd4110c3b757SPL set ID 90414d2f-7b2c-47f9-a096-2e7b7dd052deRxCUI 856656UNII 287M0347EVUPC 0309047211043
- 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
N400904721104followed by a unit qualifier and the quantityPackage 00904-7211-04. 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 are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage t…
Excerpt only. Read the full label for complete information.
About NDC 0904-7211
- What is NDC 0904-7211?
- 0904-7211 is the product NDC for Dantrolene Sodium, Dantrolene sodium 25 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dantrolene Sodium.
- What is the active ingredient?
- Dantrolene sodium.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dantrolene Sodium?
- 20 other product NDCs are listed under this name. See all Dantrolene Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dantrolene Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4668 | 70518-4668-00 |
| dantrolene sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4622 | 70518-4622-0070518-4622-02 |
| Dantrolene Sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | AvPAK | 50268-217 | 50268-0217-15 |
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-362 | 49884-0362-01 |
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-363 | 49884-0363-01 |
| dantrolene sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | Par Health USA, LLC | 49884-364 | 49884-0364-01 |
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2168 | 63629-2168-01 |
| dantrolene sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2169 | 63629-2169-01 |
| dantrolene sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1497 | 72162-1497-01 |
| Dantrolene Sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | American Health Packaging | 68084-300 | 68084-0300-21 |
Other NDCs under ANDA 076856
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 | Amneal Pharmaceuticals of New York LLC | 0115-4411 |
| Dantrolene Sodium | Dantrolene sodium 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-4422 |
| Dantrolene Sodium | Dantrolene sodium 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-4433 |
| Dantrolene Sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | AvPAK | 50268-217 |
| Dantrolene Sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-7140 |
| Dantrolene Sodium | Dantrolene sodium 25 mg/1 | CapsuleOral | American Health Packaging | 68084-300 |