Prescription drug · ANDA
Ciprofloxacin in Dextrose (Ciprofloxacin) NDC 0409-3300
Ciprofloxacin 400 mg/200mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-3300-24 | 0040933002400409330024 | 24 POUCH in 1 CARTON (0409-3300-24) / 1 BAG in 1 POUCH (0409-3300-01) / 200 mL in 1 BAGMarketed from Dec 1, 2022 |
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)
- Ciprofloxacin in Dextrose
- Generic name (nonproprietary)
- ciprofloxacin
- Active ingredients
- Ciprofloxacin — 400 mg/200mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078252
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 0409-3300_c63c8728-adee-439d-a634-07ce0a373093SPL ID c63c8728-adee-439d-a634-07ce0a373093SPL set ID cbbbf939-3219-4515-a48e-ca264daa4d07RxCUI 1665210, 1665212UNII 5E8K9I0O4U
- Pharmacologic class
- Fluoroquinolone 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
N400409330024followed by a unit qualifier and the quantityPackage 00409-3300-24. 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)
Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Nosocomial Pneumonia ( 1.4 ) Empirical Therapy for Febrile Neutropenic Patients ( 1.5 ) Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients ( 1.6 ) Plague in Adult and Pediatric Patients ( 1.7 ) Chronic Bacterial Prostatitis ( 1.8 ) Lower Respiratory Tract Infections ( 1.9 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.1…
Excerpt only. Read the full label for complete information.
About NDC 0409-3300
- What is NDC 0409-3300?
- 0409-3300 is the product NDC for Ciprofloxacin in Dextrose (ciprofloxacin), Ciprofloxacin 400 mg/200mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin in Dextrose (Ciprofloxacin).
- What is the active ingredient?
- Ciprofloxacin.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ciprofloxacin in Dextrose?
- 2 other product NDCs are listed under this name. See all Ciprofloxacin in Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciprofloxacin in Dextrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacin in Dextroseciprofloxacin | Ciprofloxacin 200 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2300 | 00409-2300-24 |
| Ciprofloxacin in Dextroseciprofloxacin | Ciprofloxacin 400 mg/200mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-300 | 84549-0300-24 |
Other NDCs under ANDA 078252
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 |
|---|---|---|---|---|
| Ciprofloxacin | Ciprofloxacin 2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-114 |
| Ciprofloxacin | Ciprofloxacin 2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-192 |
| Ciprofloxacin in Dextroseciprofloxacin | Ciprofloxacin 200 mg/100mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2300 |
| Ciprofloxacin in Dextroseciprofloxacin | Ciprofloxacin 400 mg/200mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-300 |