What is NDC 69315-308?

69315-308 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 3 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ciprofloxacin NDC 69315-308 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-308Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0308Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
69315-308-02	6931503080269315030802	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-02) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Nov 1, 2018
69315-308-05	6931503080569315030805	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Nov 1, 2018
69315-308-10	6931503081069315030810	1 BOTTLE, PLASTIC in 1 CARTON (69315-308-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Nov 1, 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
Generic name (nonproprietary): ciprofloxacin
Active ingredients: Ciprofloxacin hydrochloride — 3 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077568
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers: Product ID 69315-308_8217ec14-6498-4c35-a5a9-511b451b9459SPL ID 8217ec14-6498-4c35-a5a9-511b451b9459SPL set ID 545527e7-05c7-4dbf-ab32-b3fa463d55b0RxCUI 309307UNII 4BA73M5E37UPC 0369315308028, 0369315308059
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

N469315030802 followed by a unit qualifier and the quantity

Package 69315-0308-02. 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 May 10, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 69315-308

What is NDC 69315-308?: 69315-308 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 3 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, 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?: Leading Pharma, LLC, NDC labeler code 69315. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other ciprofloxacin NDCs
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

All 168 ciprofloxacin NDCs

Other NDCs under ANDA 077568

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077568
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	Preferred Pharmaceuticals, Inc.	68788-7500
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