Prescription drug · ANDA
Chloramphenicol Sodium Succinate NDC 63323-011
Chloramphenicol sodium succinate 1 g/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-011-15 | 63323001115 | 10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIALMarketed from Jan 12, 2001 |
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)
- Chloramphenicol Sodium Succinate
- Generic name (nonproprietary)
- chloramphenicol sodium succinate
- Active ingredients
- Chloramphenicol sodium succinate — 1 g/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062365
- Marketing start
- Listing expires
- Other FDA classes
- Amphenicols (EXT)
- Identifiers
- Product ID 63323-011_f0af962d-5024-47cf-b7a0-da9b5ff3c994SPL ID f0af962d-5024-47cf-b7a0-da9b5ff3c994SPL set ID aed29594-211d-49ef-813f-131975a8d0e3RxCUI 239200UNII 872109HX6B
- Pharmacologic class
- Amphenicol-class Antibacterial
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
N463323001115followed by a unit qualifier and the quantityPackage 63323-0011-15. 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 . This label includes a boxed warning.
About NDC 63323-011
- What is NDC 63323-011?
- 63323-011 is the product NDC for Chloramphenicol Sodium Succinate, Chloramphenicol sodium succinate 1 g/10mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chloramphenicol Sodium Succinate.
- What is the active ingredient?
- Chloramphenicol sodium succinate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chloramphenicol Sodium Succinate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.