Prescription drug · ANDA
Rifampin NDC 63323-351
Rifampin 600 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-351-20 | 63323035120 | 1 VIAL in 1 BOX (63323-351-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Aug 21, 2014 |
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)
- Rifampin
- Generic name (nonproprietary)
- rifampin
- Active ingredients
- Rifampin — 600 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091181
- Marketing start
- Listing expires
- Other FDA classes
- Rifamycins (Chemical structure)
- Identifiers
- Product ID 63323-351_60eb9c46-3c34-455b-a740-c03884565072SPL ID 60eb9c46-3c34-455b-a740-c03884565072SPL set ID a1f9f1e2-dfc0-4d31-a13b-b656d897b791RxCUI 312821UNII VJT6J7R4TRUPC 0363323351205
- Pharmacologic class
- Rifamycin 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
N463323035120followed by a unit qualifier and the quantityPackage 63323-0351-20. 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)
INDICATIONS AND USAGE In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regim…
Excerpt only. Read the full label for complete information.