Prescription drug · ANDA
Kymbee (deflazacort) NDC 0245-0813
Deflazacort 22.75 mg/mL · Suspension · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-0813-13 | 00245081313 | 1 BOTTLE in 1 CARTON (0245-0813-13) / 13 mL in 1 BOTTLEMarketed from Jun 5, 2026 |
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)
- Kymbee
- Generic name (nonproprietary)
- deflazacort
- Active ingredients
- Deflazacort — 22.75 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216992
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0245-0813_548be9b3-be2c-7d81-e063-6394a90a8793SPL ID 548be9b3-be2c-7d81-e063-6394a90a8793SPL set ID ba749cfb-813d-4799-9e7b-44ede92065f2RxCUI 1870964, 2745410UNII KR5YZ6AE4B
- 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
N400245081313followed by a unit qualifier and the quantityPackage 00245-0813-13. 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)
KYMBEE is 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 ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. KYMBEE is a 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.