NDC codes

FDA NDC Directory
Product NDC (as listed)64980-432Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0432Add 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
64980-432-01649800432011 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jul 1, 2022
64980-432-05649800432051 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jul 1, 2022

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)
Ofloxacin
Generic name (nonproprietary)
ofloxacin
Active ingredients
Ofloxacin — 3 mg/mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215038
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 64980-432_9f3f2dbd-6219-4d6f-8996-82aa77b563deSPL ID 9f3f2dbd-6219-4d6f-8996-82aa77b563deSPL set ID 2e912ed6-51e8-40c3-bf10-2af092c63be8RxCUI 242446UNII A4P49JAZ9HUPC 0364980432054, 0364980432016
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N464980043201 followed by a unit qualifier and the quantity

Package 64980-0432-01. 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 Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa Staphylococcus aure…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-432

What is NDC 64980-432?
64980-432 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 400 mg/1Tablet, Film coatedOralModavar Pharmaceuticals LLC72241-07472241-0074-0272241-0074-0572241-0074-10
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 ophthalmic solution usp, 0.3%Ofloxacin 3 mg/mLSolution/ dropsOphthalmicCaplin Steriles Limited65145-14265145-0142-01
Ofloxacinofloxacin ophthalmic solution usp, 0.3%Ofloxacin 3 mg/mLSolution/ dropsOphthalmicCaplin Steriles Limited65145-14165145-0141-01
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 215038

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

FDA NDC Directory listings under ANDA 215038
ProductStrengthForm · routeLabelerProduct NDC
OfloxacinOfloxacin 3 mg/mLSolutionAuricular (Otic)REMEDYREPACK INC.70518-4752

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