NDC codes

FDA NDC Directory
Product NDC (as listed)63323-011Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0011Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63323-011-156332300111510 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.

How CPT relates to drug billing

NDC on a medical claim

N463323001115 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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