What is NDC 70069-686?

70069-686 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Somerset Therapeutics, LLC, NDC labeler code 70069. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ofloxacin NDC 70069-686 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-686Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0686Add 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 NDC	11-digit (billing)	Package	Copy
70069-686-01	7006906860170069068601	1 BOTTLE in 1 CARTON (70069-686-01) / 5 mL in 1 BOTTLEMarketed from Oct 31, 2024

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/ drops
Route: Auricular (Otic)
Labeler: Somerset Therapeutics, LLCNDC labeler code 70069
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216328
Marketing start: Oct 31, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 70069-686_d0e8409c-4b1e-4d0b-bfa7-7e75e0a540c8SPL ID d0e8409c-4b1e-4d0b-bfa7-7e75e0a540c8SPL set ID 72ad7b86-1d5b-48c9-bb40-319d6c186f1dRxCUI 242446UNII A4P49JAZ9HUPC 0370069686010, 0370069687017
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

N470069068601 followed by a unit qualifier and the quantity

Package 70069-0686-01. 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 Oct 31, 2024.

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, 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 au…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70069-686

What is NDC 70069-686?: 70069-686 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. 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?: Somerset Therapeutics, LLC, NDC labeler code 70069. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ofloxacin	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	REMEDYREPACK INC.	70518-4752	70518-4752-00
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Preferred Pharmaceuticals Inc.	68788-4086	68788-4086-01
Ofloxacin	Ofloxacin 200 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-072	72241-0072-0272241-0072-0572241-0072-10
Ofloxacin	Ofloxacin 300 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-073	72241-0073-0272241-0073-0572241-0073-10
Ofloxacin	Ofloxacin 400 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-074	72241-0074-0272241-0074-0572241-0074-10
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-141	65145-0141-01
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-142	65145-0142-01
Ofloxacin	Ofloxacin 3 mg/mL	SolutionOphthalmic	St. Mary's Medical Park Pharmacy	60760-917	60760-0917-05
Ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Caplin Steriles Limited	65145-143	65145-0143-01
Ofloxacinofloxacin otic solution	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Caplin Steriles Limited	65145-144	65145-0144-01

All 73 Ofloxacin NDCs

Other NDCs under ANDA 216328

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

FDA NDC Directory listings under ANDA 216328
Product	Strength	Form · route	Labeler	Product NDC
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Redpharm Drug	67296-2179
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Preferred Pharmaceuticals Inc.	68788-4086
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Somerset Therapeutics, LLC	70069-687