NDC codes

FDA NDC Directory
Product NDC (as listed)60505-0560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0560Add 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 NDC11-digit (billing)PackageCopy
60505-0560-0605050560001 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 1, 2019
60505-0560-1605050560011 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 1, 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)
Ofloxacin
Generic name (nonproprietary)
ofloxacin
Active ingredients
Ofloxacin — 3 mg/mL
Dosage form
Solution
Route
Ophthalmic
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076513
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 60505-0560_546dcc18-50b8-db4a-0a19-b06b0ba3a01fSPL ID 546dcc18-50b8-db4a-0a19-b06b0ba3a01f
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

N460505056000 followed by a unit qualifier and the quantity

Package 60505-0560-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-0560

What is NDC 60505-0560?
60505-0560 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ofloxacin.
What is the active ingredient?
Ofloxacin.
Who is the labeler?
Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ofloxacin?
71 other product NDCs are listed under this name. See all Ofloxacin 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 Ofloxacin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OfloxacinOfloxacin 3 mg/mLSolutionAuricular (Otic)REMEDYREPACK INC.70518-475270518-4752-00
OfloxacinOfloxacin 3 mg/mLSolution/ dropsAuricular (Otic)Preferred Pharmaceuticals Inc.68788-408668788-4086-01
OfloxacinOfloxacin 200 mg/1Tablet, Film coatedOralModavar Pharmaceuticals LLC72241-07272241-0072-0272241-0072-0572241-0072-10
OfloxacinOfloxacin 300 mg/1Tablet, Film coatedOralModavar Pharmaceuticals LLC72241-07372241-0073-0272241-0073-0572241-0073-10
OfloxacinOfloxacin 400 mg/1Tablet, Film coatedOralModavar Pharmaceuticals LLC72241-07472241-0074-0272241-0074-0572241-0074-10
Ofloxacinofloxacin ophthalmic solution usp, 0.3%Ofloxacin 3 mg/mLSolution/ dropsOphthalmicCaplin Steriles Limited65145-14165145-0141-01
Ofloxacinofloxacin ophthalmic solution usp, 0.3%Ofloxacin 3 mg/mLSolution/ dropsOphthalmicCaplin Steriles Limited65145-14265145-0142-01
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicSt. Mary's Medical Park Pharmacy60760-91760760-0917-05
Ofloxacinofloxacin oticOfloxacin 3 mg/mLSolution/ dropsAuricular (Otic)Caplin Steriles Limited65145-14365145-0143-01
Ofloxacinofloxacin otic solutionOfloxacin 3 mg/mLSolution/ dropsAuricular (Otic)Caplin Steriles Limited65145-14465145-0144-01

All 72 Ofloxacin NDCs

Other NDCs under ANDA 076513

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

FDA NDC Directory listings under ANDA 076513
ProductStrengthForm · routeLabelerProduct NDC
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicNuCare Pharmceuticals,Inc.68071-3566
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicA-S Medication Solutions50090-5186
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicA-S Medication Solutions50090-5209
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicPreferred Pharmaceuticals Inc.68788-8761
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicProficient Rx LP71205-420
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicSt. Mary's Medical Park Pharmacy60760-917

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