Prescription drug · ANDA
Ciprofloxacin (Ciprofolxacin) NDC 43547-689
Ciprofloxacin hydrochloride 500 mg/1 · Tablet · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-689-10 | 4354706891043547068910 | 100 TABLET in 1 BOTTLE (43547-689-10)Marketed from Oct 1, 2023 | |
| 43547-689-50 | 4354706895043547068950 | 500 TABLET in 1 BOTTLE (43547-689-50)Marketed from Oct 1, 2023 |
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)
- ciprofolxacin
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- 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 43547-689_d02ca299-0a85-451c-990e-eb006905fd0aSPL ID d02ca299-0a85-451c-990e-eb006905fd0aSPL set ID b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3RxCUI 197511, 309309UNII 4BA73M5E37UPC 0343547689100, 0343547688103
- 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
N443547068910followed by a unit qualifier and the quantityPackage 43547-0689-10. 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 ) o Acute Exacerbatio…
Excerpt only. Read the full label for complete information.
About NDC 43547-689
- What is NDC 43547-689?
- 43547-689 is the product NDC for Ciprofloxacin (ciprofolxacin), Ciprofloxacin hydrochloride 500 mg/1 tablet, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin (Ciprofolxacin).
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Solco Healthcare US, LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ciprofloxacin?
- 167 other product NDCs are listed under this name. See all Ciprofloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciprofloxacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-947 | 60687-0947-01 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-102 | 82868-0102-0682868-0102-1482868-0102-20 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0193 | 55154-0193-00 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-627 | 72189-0627-1072189-0627-14 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8875 | 68788-8875-0068788-8875-0168788-8875-02+4 more |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-623 | 72189-0623-1072189-0623-1472189-0623-20 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-690 | 60760-0690-10 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2291 | 67296-2291-04 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8630 | 00615-8630-1000615-8630-1400615-8630-20 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-976 | 59651-0976-0159651-0976-2059651-0976-30+1 more |
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 |
|---|---|---|---|---|
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-2383 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-2384 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceutical, Inc. | 68071-3737 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2450 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-2404 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-7297 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8692 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4133 |
| Ciprofloxacinciprofloxacin tablets | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-1152 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-749 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2502 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | Redpharm Drug | 67296-1848 |
| Ciprofloxacinciprofloxacin tablets | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-1229 |
| Ciprofloxacinciprofloxacin tablets | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Yiling Pharmaceutical, Inc. | 69117-0008 |
| Ciprofloxacinciprofloxacin tablets | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, CoatedOral | Yiling Pharmaceutical, Inc. | 69117-0009 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 82804-256 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Coupler LLC | 67046-1460 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, CoatedOral | Direct Rx | 72189-323 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4229 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3610 |
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