Prescription drug · ANDA
Ciprofloxacin (ciprofloxacin hydrochloride) NDC 43063-923
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-923-30 | 43063092330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-923-30)Marketed from May 10, 2019 |
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 hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 500 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 076126
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 43063-923_42ef92d0-be54-bc1c-e063-6294a90aa576SPL ID 42ef92d0-be54-bc1c-e063-6294a90aa576SPL set ID cfda82e4-8660-447e-a881-b87165a31e9aRxCUI 309309UNII 4BA73M5E37UPC 0343063923207
- 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
N443063092330followed by a unit qualifier and the quantityPackage 43063-0923-30. 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 Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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 Exacer…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076126
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 |
|---|---|---|---|---|
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4600 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1010 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-165 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-081 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-109 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-224 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-222 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-223 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-065 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-776 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-775 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-997 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-547 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7581 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1347 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1740 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1741 |