Prescription drug · ANDA
ciprofloxacin NDC 50090-1649
Ciprofloxacin hydrochloride 500 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1649-0 | 50090164900 | 20 TABLET in 1 BOTTLE (50090-1649-0)Marketed from Jan 19, 2015 | |
| 50090-1649-1 | 50090164901 | 14 TABLET in 1 BOTTLE (50090-1649-1)Marketed from Oct 31, 2023 |
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
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076639
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 50090-1649_9244d2d7-3da2-46a0-a870-9d1196df1504SPL ID 9244d2d7-3da2-46a0-a870-9d1196df1504SPL set ID 6971a958-08f0-4712-bf5f-47fe4f76b863RxCUI 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
N450090164900followed by a unit qualifier and the quantityPackage 50090-1649-00. 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 Exacerbation of Chronic Bronchi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076639
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 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-716 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | Proficient Rx LP | 63187-990 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-919 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-192 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-869 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0408 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | Coupler LLC | 67046-1528 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-413 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | PharmPak, Inc. | 54348-662 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-411 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-412 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | PharmPak, Inc. | 54348-663 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0193 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-410 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Umasuto, LLC | 85293-003 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Umasuto, LLC | 85293-002 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | Umasuto, LLC | 85293-004 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0070 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Proficient Rx LP | 63187-017 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-102 |
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