Prescription drug · ANDA
Ciprofloxacin HCL NDC 80425-0192
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0192-1 | 8042501920180425019201 | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0192-1)Marketed from Jun 24, 2024 | |
| 80425-0192-2 | 8042501920280425019202 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0192-2)Marketed from Jun 24, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCL
- Generic name (nonproprietary)
- ciprofloxacin hcl
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077859
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 80425-0192_509c72a9-b580-72a3-e063-6394a90ad351SPL ID 509c72a9-b580-72a3-e063-6394a90ad351SPL set ID e237dd23-faf3-1765-e053-2a95a90ae62dRxCUI 309309UNII 4BA73M5E37
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425019201followed by a unit qualifier and the quantityPackage 80425-0192-01. 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)
1. Indications and Usage 1.1 Skin and Skin Structure Infections Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. 1.2 Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginos…
Excerpt only. Read the full label for complete information.
About NDC 80425-0192
- What is NDC 80425-0192?
- 80425-0192 is the product NDC for Ciprofloxacin HCL, Ciprofloxacin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin HCL.
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 HCL?
- 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.
Other NDCs under ANDA 077859
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 |
|---|---|---|---|---|
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8630 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-088 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2146 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3791 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3852 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5373 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-216 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-866 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-867 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-873 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-976 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-860 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-947 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-076 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-077 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-078 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2291 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8136 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4214 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-636 |
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