Prescription drug · ANDA
Ciprofloxacin NDC 72189-300
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-300-06 | 72189030006 | 6 TABLET, FILM COATED in 1 BOTTLE (72189-300-06)Marketed from Dec 3, 2021 | |
| 72189-300-20 | 72189030020 | 20 TABLET, FILM COATED in 1 BOTTLE (72189-300-20)Marketed from Dec 3, 2021 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- DirectRx
- 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 72189-300_2c294bda-345b-ad0e-e063-6294a90a0304SPL ID 2c294bda-345b-ad0e-e063-6294a90a0304SPL set ID d23e359d-6d12-38f6-e053-2a95a90a0a88RxCUI 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
N472189030006followed by a unit qualifier and the quantityPackage 72189-0300-06. 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 .
Indications (excerpt from the label)
1.1 Skin and Skin Structure Infections Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. 1.2 Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. 1.3 Complicated Intra-…
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 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-124 |
| 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 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 |