Prescription drug · ANDA
Ciprofloxacin (ciprofloxacin tablets) NDC 69117-0009
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Coated · Oral · Yiling Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0009-1 | 69117000901 | 500 TABLET, COATED in 1 BOTTLE (69117-0009-1)Marketed from Jul 13, 2019 | |
| 69117-0009-2 | 69117000902 | 100 TABLET, COATED in 1 BOTTLE (69117-0009-2)Marketed from Jul 13, 2019 |
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
- Generic name (nonproprietary)
- ciprofloxacin tablets
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Yiling Pharmaceutical, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208921
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 69117-0009_47236eca-557e-1b27-e063-6394a90acd14SPL ID 47236eca-557e-1b27-e063-6394a90acd14SPL set ID 6fd3da0b-7428-ac8f-e053-2a91aa0aed9fRxCUI 197511, 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
N469117000901followed by a unit qualifier and the quantityPackage 69117-0009-01. 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208921
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 |
|---|---|---|---|---|
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Coupler LLC | 67046-1460 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-519 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4229 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3610 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | St. Mary's Medical Park Pharmacy | 60760-676 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 51655-490 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-928 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Proficient Rx LP | 82804-130 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-929 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-690 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-689 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Redpharm Drug | 67296-2135 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2097 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3901 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Method Pharmaceuticals, LLC | 58657-675 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0492 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | Method Pharmaceuticals, LLC | 58657-676 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Redpharm Drug | 67296-2169 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Coupler LLC | 67046-1537 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8200 |
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