Prescription drug · ANDA
Ciprofloxacin Hydrochloride NDC 68788-4177
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4177-0 | 68788417700 | 6 TABLET, FILM COATED in 1 BOTTLE (68788-4177-0)Marketed from Jul 31, 2026 | |
| 68788-4177-1 | 68788417701 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-4177-1)Marketed from Jul 31, 2026 | |
| 68788-4177-2 | 68788417702 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-4177-2)Marketed from Jul 31, 2026 | |
| 68788-4177-3 | 68788417703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4177-3)Marketed from Jul 31, 2026 | |
| 68788-4177-8 | 68788417708 | 10 TABLET, FILM COATED in 1 BOTTLE (68788-4177-8)Marketed from Jul 31, 2026 |
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 Hydrochloride
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 68788-4177_b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5SPL ID b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5SPL set ID b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5RxCUI 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
N468788417700followed by a unit qualifier and the quantityPackage 68788-4177-00. 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.
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 | Coupler LLC | 67046-1692 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 |
| 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 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 |
| 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 | Redpharm Drug | 67296-2208 |
| 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 | Proficient Rx LP | 82804-260 |