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 | 5965106013059651060130 | 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 LimitedNDC labeler code 59651
- 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.
About NDC 59651-601
- What is NDC 59651-601?
- 59651-601 is the product NDC for Deflazacort, Deflazacort 30 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deflazacort.
- What is the active ingredient?
- Deflazacort.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deflazacort?
- 31 other product NDCs are listed under this name. See all Deflazacort NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deflazacort products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0824 | 00054-0824-25 |
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0825 | 00054-0825-13 |
| Deflazacort | Deflazacort 30 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0826 | 00054-0826-13 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0827 | 00054-0827-13 |
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2282 | 60219-2282-01 |
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2283 | 60219-2283-01 |
| Deflazacort | Deflazacort 30 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2284 | 60219-2284-01 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2285 | 60219-2285-01 |
| Deflazacort | Deflazacort 6 mg/1 | TabletOral | AvKARE | 73190-068 | 73190-0068-01 |
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | AvKARE | 73190-069 | 73190-0069-30 |
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 6 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-599 |
| Deflazacort | Deflazacort 18 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-600 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-602 |