Prescription drug · NDA AUTHORIZED GENERIC
Ciprofloxacin Hydrochloride NDC 68788-8198
Ciprofloxacin hydrochloride 3 mg/mL · Solution/ drops · Ophthalmic · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8198-5 | 68788819805 | 1 BOTTLE, PLASTIC in 1 CARTON (68788-8198-5) / 5 mL in 1 BOTTLE, PLASTICMarketed from May 23, 2022 |
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 Hydrochloride
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019992
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 68788-8198_6382ad56-0b87-4376-896e-97ce0f08028fSPL ID 6382ad56-0b87-4376-896e-97ce0f08028fSPL set ID 78641acd-eedf-4b68-bb18-da0874415f59RxCUI 309307UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468788819805followed by a unit qualifier and the quantityPackage 68788-8198-05. 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 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 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.
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 | NuCare Pharmaceuticals,Inc. | 68071-4235 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Asclemed USA, Inc. | 76420-942 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-985 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1754 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-0882 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3351 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 61314-656 |
| Ciprofloxacin Hydrochloride | Ciprofloxacin hydrochloride 3 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-1170 |
| 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. | 68071-4139 |