Prescription drug · ANDA
Deflazacort NDC 70095-041
Deflazacort 18 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70095-041-30 | 70095004130 | 1 BOTTLE in 1 CARTON (70095-041-30) / 30 TABLET in 1 BOTTLEMarketed from Mar 19, 2025 |
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 — 18 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217741
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70095-041_4583474c-40e7-dd9d-e063-6294a90a902aSPL ID 4583474c-40e7-dd9d-e063-6294a90a902aSPL set ID fb5350d5-ead1-41f4-8b25-0da0bd7fcffeRxCUI 153098, 153880, 1870954, 1870958UNII KR5YZ6AE4BUPC 0370095040015, 0370095043306, 0370095042309, 0370095041302
- 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
N470095004130followed by a unit qualifier and the quantityPackage 70095-0041-30. 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 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Deflazacort tablets are corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217741
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 | Sun Pharmaceutical Industries, Inc. | 70095-040 |
| Deflazacort | Deflazacort 30 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 70095-042 |
| Deflazacort | Deflazacort 36 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 70095-043 |