Prescription drug · ANDA
Ciprofloxacin NDC 69238-2432
Ciprofloxacin hydrochloride 250 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2432-1 | 69238243201 | 100 TABLET, FILM COATED in 1 BOTTLE (69238-2432-1)Marketed from Feb 29, 2024 |
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 — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075939
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 69238-2432_d44c6eb1-e419-4bee-977a-b1b46444595fSPL ID d44c6eb1-e419-4bee-977a-b1b46444595fSPL set ID b996e81b-36ec-4ad7-a7c4-bc6700a06648RxCUI 197511, 197512, 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
N469238243201followed by a unit qualifier and the quantityPackage 69238-2432-01. 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 tablets are 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 of Chronic Bronchitis Urinary T…
Excerpt only. Read the full label for complete information.
About NDC 69238-2432
- What is NDC 69238-2432?
- 69238-2432 is the product NDC for Ciprofloxacin, Ciprofloxacin hydrochloride 250 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin.
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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?
- 168 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 | 82868-0102-1482868-0102-20 |
| 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8630 | 00615-8630-1000615-8630-1400615-8630-20 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-977 | 59651-0977-0159651-0977-0559651-0977-20+2 more |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-978 | 59651-0978-0159651-0978-0559651-0978-20+2 more |
Other NDCs under ANDA 075939
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 | Amneal Pharmaceuticals NY LLC | 69238-2433 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2434 |