Prescription drug · ANDA
Deflazacort Oral Suspension (Deflazacort oral) NDC 57664-993
Deflazacort 22.75 mg/mL · Suspension · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-993-01 | 5766409930157664099301 | 13 mL in 1 BOTTLE (57664-993-01)Marketed from Feb 2, 2026 |
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 Oral Suspension
- Generic name (nonproprietary)
- deflazacort oral
- Active ingredients
- Deflazacort — 22.75 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219930
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 57664-993_58eacdfa-dd04-ff7e-e063-6294a90ad0dfSPL ID 58eacdfa-dd04-ff7e-e063-6294a90ad0dfSPL set ID 2fac1332-0247-1047-e063-6294a90a557fRxCUI 1870964UNII KR5YZ6AE4BUPC 0357664993019
- 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
N457664099301followed by a unit qualifier and the quantityPackage 57664-0993-01. 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 .
Indications (excerpt from the label)
Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Deflazacort oral suspension 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 57664-993
- What is NDC 57664-993?
- 57664-993 is the product NDC for Deflazacort Oral Suspension (deflazacort oral), Deflazacort 22.75 mg/mL suspension, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deflazacort Oral Suspension (Deflazacort Oral).
- What is the active ingredient?
- Deflazacort.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 Oral Suspension?
- 4 other product NDCs are listed under this name. See all Deflazacort Oral Suspension NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deflazacort Oral Suspension 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 Oral Suspensiondeflazacort oral | Deflazacort 22.75 mg/mL | SuspensionOral | Biocon Pharma Inc. | 70377-188 | 70377-0188-21 |
| Deflazacort Oral Suspensiondeflazacort | Deflazacort 22.75 mg/mL | SuspensionOral | Zydus Pharmaceuticals (USA) Inc. | 70710-2007 | 70710-2007-03 |
| Deflazacort Oral Suspensiondeflazacort | Deflazacort 22.75 mg/mL | SuspensionOral | Doppel Farmaceutici S.r.l. | 81806-200 | 81806-0200-73 |
| Deflazacort Oral Suspensiondeflazacort oral | Deflazacort 22.75 mg/mL | SuspensionOral | Cranbury Pharmaceuticals, LLC | 27808-249 | 27808-0249-01 |