Prescription drug · NDA
Metronidazole NDC 0264-5535
Metronidazole 500 mg/100mL · Solution · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-5535-32 | 0026455353200264553532 | 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINERMarketed from Sep 29, 1983 |
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)
- Metronidazole
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 500 mg/100mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018900
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 0264-5535_d16a1d82-f9ec-4c94-a9d6-0ccaba6dca82SPL ID d16a1d82-f9ec-4c94-a9d6-0ccaba6dca82SPL set ID fd191c06-9d3b-4e46-9f79-90f6af614947RxCUI 311683UNII 140QMO216E
- Pharmacologic class
- Nitroimidazole Antimicrobial
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
N400264553532followed by a unit qualifier and the quantityPackage 00264-5535-32. 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.
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection USP and other antibacterial drugs, Metronidazole Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. TREATMENT OF ANAEROBIC INFECTIONS Metronidazole Injection is indicated in the treatment of serious infections cause…
Excerpt only. Read the full label for complete information.
About NDC 0264-5535
- What is NDC 0264-5535?
- 0264-5535 is the product NDC for Metronidazole, Metronidazole 500 mg/100mL solution, listed with the FDA by B. Braun Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metronidazole.
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- B. Braun Medical Inc., NDC labeler code 0264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metronidazole?
- 160 other product NDCs are listed under this name. See all Metronidazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metronidazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4767 | 70518-4767-00 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-024 | 85742-0024-2485742-0024-25 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-025 | 85742-0025-2485742-0025-25 |
| Metronidazole | Metronidazole 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2677 | 72162-2677-0172162-2677-0272162-2677-05 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2678 | 72162-2678-0172162-2678-0272162-2678-05 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1060 | 67046-1060-03 |
| Metronidazole | Metronidazole 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1173 | 67046-1173-03 |
| Metronidazole | Metronidazole 7.5 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1978 | 70771-1978-04 |
| Metronidazole | Metronidazole 7.5 mg/g | GelTopical | Viona Pharmaceuticals Inc | 72578-209 | 72578-0209-04 |
| Metronidazole | Metronidazole 7.5 mg/g | GelVaginal | Solaris Pharma Corporation | 73473-303 | 73473-0303-70 |