Prescription drug · ANDA
Ciprofloxacin Hydrochloride NDC 83939-0002
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · VERITYRX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83939-0002-1 | 83939000201 | 1 TABLET, FILM COATED in 1 POUCH (83939-0002-1)Marketed from Nov 3, 2025 | |
| 83939-0002-2 | 83939000202 | 50 POUCH in 1 BOX, UNIT-DOSE (83939-0002-2) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Nov 3, 2025 | |
| 83939-0002-3 | 83939000203 | 100 POUCH in 1 BOX, UNIT-DOSE (83939-0002-3) / 1 TABLET, FILM COATED in 1 POUCHMarketed from Nov 3, 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 Hydrochloride
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- VERITYRX, LLC
- 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 83939-0002_42543e8f-06f4-2b34-e063-6394a90a4abbSPL ID 42543e8f-06f4-2b34-e063-6394a90a4abbSPL set ID 42542f65-84a7-fdab-e063-6394a90a1095RxCUI 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
N483939000201followed by a unit qualifier and the quantityPackage 83939-0002-01. 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)
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 ) Acute Exacerbation of Chronic Bronchiti…
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 | Preferred Pharmaceuticals Inc | 68788-4177 |
| 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 | 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 |