Prescription drug · ANDA
ciprofloxacin NDC 68788-7500
Ciprofloxacin hydrochloride 3 mg/mL · Solution · Ophthalmic · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7500-5 | 6878875000568788750005 | 1 BOTTLE, PLASTIC in 1 CARTON (68788-7500-5) / 5 mL in 1 BOTTLE, PLASTICMarketed from Nov 30, 2019 |
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 — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077568
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 68788-7500_bbc3e786-14b4-4048-8c0e-8d00a79e02f0SPL ID bbc3e786-14b4-4048-8c0e-8d00a79e02f0SPL set ID 85c48ebc-d94a-4254-86df-d2c1aff09b37RxCUI 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
N468788750005followed by a unit qualifier and the quantityPackage 68788-7500-05. 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 68788-7500
- What is NDC 68788-7500?
- 68788-7500 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 3 mg/mL solution, listed with the FDA by Preferred Pharmaceuticals, Inc.. 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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?
- 167 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 | 82868-0102-0682868-0102-1482868-0102-20 |
| 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 | Redpharm Drug | 67296-2291 | 67296-2291-04 |
| 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 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-976 | 59651-0976-0159651-0976-2059651-0976-30+1 more |
Other NDCs under ANDA 077568
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 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-4217 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-1703 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4672 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4679 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-308 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-300 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-588 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Advanced Rx of Tennessee, LLC | 80425-0499 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | HAWAII REPACK, INC | 85534-0075 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-023 |