Prescription drug · ANDA
Ciprofloxacin Hydrochloride NDC 82804-260
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-260-06 | 8280402600682804026006 | 6 TABLET, FILM COATED in 1 BOTTLE (82804-260-06)Marketed from Jun 1, 2026 | |
| 82804-260-07 | 8280402600782804026007 | 7 TABLET, FILM COATED in 1 BOTTLE (82804-260-07)Marketed from Apr 20, 2026 | |
| 82804-260-10 | 8280402601082804026010 | 10 TABLET, FILM COATED in 1 BOTTLE (82804-260-10)Marketed from Mar 12, 2026 | |
| 82804-260-14 | 8280402601482804026014 | 14 TABLET, FILM COATED in 1 BOTTLE (82804-260-14)Marketed from Dec 30, 2025 | |
| 82804-260-20 | 8280402602082804026020 | 20 TABLET, FILM COATED in 1 BOTTLE (82804-260-20)Marketed from Dec 30, 2025 | |
| 82804-260-30 | 8280402603082804026030 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-260-30)Marketed from Aug 4, 2026 |
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)
- Ciprofloxacin Hydrochloride
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076593
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 82804-260_395e75a6-afab-4888-84c5-73c1d5e44e75SPL ID 395e75a6-afab-4888-84c5-73c1d5e44e75SPL set ID b281a5c0-5f3e-4e6f-86ac-ed7794aac64cRxCUI 309309UNII 4BA73M5E37UPC 0382804260140
- 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
N482804026006followed by a unit qualifier and the quantityPackage 82804-0260-06. 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 is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) 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 ) • Infectious Diarrhea ( 1.4 ) • Typhoid Fever (Enteric Fever) ( 1.5 ) • Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) • Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) • Plague in adult and pediatric patients ( 1.8 ) • Chronic Bacterial Prostatitis ( 1.9 ) • Lower Respiratory Tract Infections ( 1.10 ) o Acute Exacerbatio…
Excerpt only. Read the full label for complete information.
About NDC 82804-260
- What is NDC 82804-260?
- 82804-260 is the product NDC for Ciprofloxacin Hydrochloride, Ciprofloxacin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin Hydrochloride.
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 Hydrochloride?
- 24 other product NDCs are listed under this name. See all Ciprofloxacin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciprofloxacin Hydrochloride 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 Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-847 | 60760-0847-20 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1692 | 67046-1692-03 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-4177 | 68788-4177-0068788-4177-0168788-4177-02+2 more |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0493 | 80425-0493-0180425-0493-02 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7843 | 50090-7843-0050090-7843-0150090-7843-03+4 more |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7848 | 50090-7848-01 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2208 | 67296-2208-02 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-385 | 69367-0385-01 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-386 | 69367-0386-0169367-0386-05 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 | 69367-0387-50 |
Other NDCs under ANDA 076593
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 Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7843 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7848 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-847 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1692 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2208 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-4177 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-385 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-386 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-577 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0493 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0002 |