Prescription drug · ANDA
Ciprofloxacin HCl Ophthalmic (Ciprofloxacin hydrochloride) NDC 59390-217
Ciprofloxacin hydrochloride 3 mg/mL · Solution · Ophthalmic · Altaire Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59390-217-02 | 5939002170259390021702 | 2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02)Marketed from May 4, 2018 | |
| 59390-217-05 | 5939002170559390021705 | 5 mL in 1 BOTTLE, PLASTIC (59390-217-05)Marketed from May 4, 2018 | |
| 59390-217-10 | 5939002171059390021710 | 10 mL in 1 BOTTLE, PLASTIC (59390-217-10)Marketed from May 4, 2018 |
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 HCl Ophthalmic
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Altaire Pharmaceuticals Inc.NDC labeler code 59390
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204613
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bbSPL ID f31149b7-60fc-4cef-8270-5eb8ff2b42bbSPL set ID 41363a06-d6f5-4bc6-b0e9-34e5616ae387RxCUI 309307UNII 4BA73M5E37UPC 4776638217054
- 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
N459390021702followed by a unit qualifier and the quantityPackage 59390-0217-02. 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, USP 0.3% 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 influenza 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 59390-217
- What is NDC 59390-217?
- 59390-217 is the product NDC for Ciprofloxacin HCl Ophthalmic (ciprofloxacin hydrochloride), Ciprofloxacin hydrochloride 3 mg/mL solution, listed with the FDA by Altaire Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin HCl Ophthalmic (Ciprofloxacin Hydrochloride).
- What is the active ingredient?
- Ciprofloxacin hydrochloride.
- Who is the labeler?
- Altaire Pharmaceuticals Inc., NDC labeler code 59390. 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 HCl Ophthalmic?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.