Prescription drug · NDA AUTHORIZED GENERIC
Ciprofloxacin Hydrochloride NDC 61314-656
Ciprofloxacin hydrochloride 3 mg/mL · Solution/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-656-05 | 6131406560561314065605 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from May 7, 2004 | |
| 61314-656-10 | 6131406561061314065610 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from May 7, 2004 | |
| 61314-656-25 | 6131406562561314065625 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-656-25) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from May 7, 2004 |
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 — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019992
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6SPL ID 1c86f423-a99a-4e4d-9502-42799a9d40e6SPL set ID ab52b14d-345b-47ff-a832-465caddd3801RxCUI 309307UNII 4BA73M5E37UPC 0361314656100
- Pharmacologic class
- Quinolone Antimicrobial
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461314065605followed by a unit qualifier and the quantityPackage 61314-0656-05. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group)* Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Excerpt only. Read the full label for complete information.
About NDC 61314-656
- What is NDC 61314-656?
- 61314-656 is the product NDC for Ciprofloxacin Hydrochloride, Ciprofloxacin hydrochloride 3 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 3 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?
- Sandoz Inc, NDC labeler code 61314. 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 500 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-386 | 69367-0386-0169367-0386-05 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-387 | 69367-0387-50 |
Other NDCs under NDA 019992
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 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-0882 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1754 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-985 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-0142 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3351 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4139 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4235 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8198 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-1170 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Asclemed USA, Inc. | 76420-942 |