Prescription drug · ANDA
Ciprofloxacin NDC 72789-124
Ciprofloxacin hydrochloride 250 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-124-01 | 72789012401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-124-01)Marketed from Oct 7, 2020 |
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
- Generic name (nonproprietary)
- ciprofloxacin
- Active ingredients
- Ciprofloxacin hydrochloride — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076558
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 72789-124_2d675959-9721-1fd0-e063-6294a90aad29SPL ID 2d675959-9721-1fd0-e063-6294a90aad29SPL set ID 5723eaf9-8659-4730-b792-4e4c33690ccbRxCUI 197511, 197512UNII 4BA73M5E37UPC 0372789125503, 0372789124018
- 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
N472789012401followed by a unit qualifier and the quantityPackage 72789-0124-01. 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 076558
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 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3063 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3868 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-086 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9927 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1867 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9928 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9929 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-108 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-118 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-125 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-042 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-300 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-304 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-193 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2837 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-214 |