NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5425Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5425Add 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
50090-5425-0500905425001 BOTTLE, PLASTIC in 1 CARTON (50090-5425-0) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jan 8, 2021

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
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078559
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 50090-5425_73ce8dc2-0fdd-4b1c-b144-9a7a3ded8b80SPL ID 73ce8dc2-0fdd-4b1c-b144-9a7a3ded8b80SPL set ID 537c6351-c7f1-47c9-95de-011bac850768RxCUI 312075UNII 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 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

N450090542500 followed by a unit qualifier and the quantity

Package 50090-5425-00. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens * Streptococcus pneumoniae Anaerobic species : Propionibacterium acnes * Efficacy for this organism was studied in fewer t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-5425

What is NDC 50090-5425?
50090-5425 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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 078559

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

FDA NDC Directory listings under ANDA 078559
ProductStrengthForm · routeLabelerProduct NDC
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicST. MARY'S MEDICAL PARK PHARMACY60760-970
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicProficient Rx LP63187-734
OfloxacinOfloxacin 3 mg/mLSolutionOphthalmicRising Pharma Holdings, Inc.64980-515

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