Prescription drug · ANDA
Deflazacort NDC 59651-601
Deflazacort 30 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-601-30 | 59651060130 | 30 TABLET in 1 BOTTLE (59651-601-30)Marketed from Feb 9, 2024 |
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)
- Deflazacort
- Generic name (nonproprietary)
- deflazacort
- Active ingredients
- Deflazacort — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217123
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59651-601_a6a915ee-9df8-46ee-a6b7-794834417917SPL ID a6a915ee-9df8-46ee-a6b7-794834417917SPL set ID 77d7525d-89c9-4fde-a6a8-0a463fd6cfebRxCUI 153098, 153880, 1870954, 1870958UNII KR5YZ6AE4BUPC 0359651600306
- Pharmacologic class
- Corticosteroid
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
N459651060130followed by a unit qualifier and the quantityPackage 59651-0601-30. 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)
Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217123
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 |
|---|---|---|---|---|
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-600 |
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-599 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-602 |