Prescription drug · ANDA
ciprofloxacin NDC 80425-0499
Ciprofloxacin hydrochloride 3 mg/mL · Solution · Ophthalmic · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0499-1 | 8042504990180425049901 | 1 BOTTLE, PLASTIC in 1 CARTON (80425-0499-1) / 5 mL in 1 BOTTLE, PLASTICMarketed from Mar 20, 2025 |
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
- Generic name (nonproprietary)
- ciprofloxacin
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077568
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 80425-0499_30cb2b47-f440-5e22-e063-6294a90a8b3dSPL ID 30cb2b47-f440-5e22-e063-6294a90a8b3dSPL set ID 30cb2b42-aa4b-8cec-e063-6394a90aa615RxCUI 309307UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425049901followed by a unit qualifier and the quantityPackage 80425-0499-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 80425-0499
- What is NDC 80425-0499?
- 80425-0499 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 3 mg/mL solution, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ciprofloxacin.
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Advanced Rx 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?
- 167 other product NDCs are listed under this name. See all ciprofloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ciprofloxacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-947 | 60687-0947-01 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-102 | 82868-0102-0682868-0102-1482868-0102-20 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0193 | 55154-0193-00 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-627 | 72189-0627-1072189-0627-14 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8875 | 68788-8875-0068788-8875-0168788-8875-02+4 more |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-623 | 72189-0623-1072189-0623-1472189-0623-20 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-690 | 60760-0690-10 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2291 | 67296-2291-04 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8630 | 00615-8630-1000615-8630-1400615-8630-20 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-976 | 59651-0976-0159651-0976-2059651-0976-30+1 more |
Other NDCs under ANDA 077568
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 hydrochloride 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-4217 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-1703 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4672 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4679 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals, Inc. | 68788-7500 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-308 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-300 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-588 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | HAWAII REPACK, INC | 85534-0075 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-023 |