Prescription drug · ANDA
Ciprofloxacin Hydrochloride NDC 69367-386
Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69367-386Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0386Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-386-01 | 6936703860169367038601 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-386-01)Marketed from May 23, 2024 | |
| 69367-386-05 | 6936703860569367038605 | 500 TABLET, FILM COATED in 1 BOTTLE (69367-386-05)Marketed from May 23, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076593
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 69367-386_6848cadf-f18e-4887-9beb-eb0586940694SPL ID 6848cadf-f18e-4887-9beb-eb0586940694
- 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
N469367038601followed by a unit qualifier and the quantityPackage 69367-0386-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69367-386
- What is NDC 69367-386?
- 69367-386 is the product NDC for Ciprofloxacin Hydrochloride, Ciprofloxacin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin Hydrochloride.
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 Hydrochloride?
- 24 other product NDCs are listed under this name. See all Ciprofloxacin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciprofloxacin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-847 | 60760-0847-20 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1692 | 67046-1692-03 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-4177 | 68788-4177-0068788-4177-0168788-4177-02+2 more |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0493 | 80425-0493-0180425-0493-02 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7843 | 50090-7843-0050090-7843-0150090-7843-03+4 more |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7848 | 50090-7848-01 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2208 | 67296-2208-02 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-385 | 69367-0385-01 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 | 69367-0387-50 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-577 | 72789-0577-0672789-0577-1072789-0577-14+2 more |
Other NDCs under ANDA 076593
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 Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7843 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7848 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-847 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1692 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2208 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-4177 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-385 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-577 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0493 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-260 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0002 |