NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1925Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1925Add 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
67296-1925-167296192501672961925011 BOTTLE, DROPPER in 1 CARTON (67296-1925-1) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 17, 2008

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
Auricular (Otic)
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076128
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 67296-1925_4727d005-5aef-1d14-e063-6294a90a04e5SPL ID 4727d005-5aef-1d14-e063-6294a90a04e5SPL set ID 2fbd51a5-462c-4741-e063-6394a90a0d87RxCUI 242446UNII A4P49JAZ9H
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

N467296192501 followed by a unit qualifier and the quantity

Package 67296-1925-01. 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 , Staphyloco…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67296-1925

What is NDC 67296-1925?
67296-1925 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution, listed with the FDA by Redpharm Drug. It has 1 package NDC, 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?
Redpharm Drug, NDC labeler code 67296. 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?
72 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 73 Ofloxacin NDCs

Other NDCs under ANDA 076128

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

FDA NDC Directory listings under ANDA 076128
ProductStrengthForm · routeLabelerProduct NDC
OfloxacinOfloxacin 3 mg/mLSolutionAuricular (Otic)Bausch & Lomb Incorporated24208-410
OfloxacinOfloxacin 3 mg/mLSolutionAuricular (Otic)Proficient Rx LP63187-472

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