NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3710Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3710Add 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
70518-3710-0705183710001 BOTTLE, DROPPER in 1 CARTON (70518-3710-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 11, 2023

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/ drops
Route
Ophthalmic
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215886
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 70518-3710_4f80ab3f-e538-c00d-e063-6394a90ad7dbSPL ID 4f80ab3f-e538-c00d-e063-6394a90ad7dbSPL set ID d97651cc-d9ea-4be4-8ea1-3d0278582dd5RxCUI 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

N470518371000 followed by a unit qualifier and the quantity

Package 70518-3710-00. 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: *Efficacy for this organism was studied in fewer than 10 infections 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3710

What is NDC 70518-3710?
70518-3710 is the product NDC for ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 215886

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

FDA NDC Directory listings under ANDA 215886
ProductStrengthForm · routeLabelerProduct NDC
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicMajor Pharmaceuticals0904-7434
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-6794
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-7761
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-3448
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicNuCare Pharmaceuticals, Inc.68071-3919
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicPreferred Pharmaceuticals Inc.68788-8449
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicLifestar Pharma LLC70756-607
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicLifestar Pharma LLC70756-650
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicNorthStar RxLLC72603-192
ofloxacinOfloxacin 3 mg/mLSolution/ dropsOphthalmicProficient Rx LP82804-101
Ofloxacin Ophth SolnOfloxacin 3 mg/mLSolution/ dropsOphthalmicDirect_Rx72189-472

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