Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 63323-506
Dexamethasone sodium phosphate 10 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-506-01 | 63323050601 | 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL (63323-506-00)Marketed from May 29, 2003 | |
| 63323-506-13 | 63323050613 | 25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03)Marketed from Jan 6, 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)
- Dexamethasone Sodium Phosphate
- Generic name (nonproprietary)
- dexamethasone sodium phosphate
- Active ingredients
- Dexamethasone sodium phosphate — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040491
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63323-506_2ce90eb7-067d-4f1c-9184-c250e387e533SPL ID 2ce90eb7-067d-4f1c-9184-c250e387e533SPL set ID cca2c160-9188-48e8-9505-49a52388dcb7RxCUI 309696, 1812079UNII AI9376Y64PUPC 0363323506001, 0363323516017, 0363323506032
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323050601followed by a unit qualifier and the quantityPackage 63323-0506-01. 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 .
Other NDCs under ANDA 040491
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 |
|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sportpharm LLC | 85766-071 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sportpharm LLC | 85766-186 |