What is NDC 71209-099?

71209-099 is the product NDC for Ofloxacin, Ofloxacin 400 mg/1 tablet, film coated, listed with the FDA by Cadila Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ofloxacin NDC 71209-099 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-099Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0099Add 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
71209-099-02	71209009902	100 TABLET, FILM COATED in 1 BOTTLE (71209-099-02)Marketed from Dec 29, 2015
71209-099-05	71209009905	500 TABLET, FILM COATED in 1 BOTTLE (71209-099-05)Marketed from Dec 29, 2015
71209-099-10	71209009910	50 TABLET, FILM COATED in 1 BOTTLE (71209-099-10)Marketed from Dec 29, 2015

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 — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Cadila Pharmaceuticals LimitedNDC labeler code 71209
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091656
Marketing start: Dec 29, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 71209-099_85ff09b7-6b73-44bd-a654-11fbab9efdbeSPL ID 85ff09b7-6b73-44bd-a654-11fbab9efdbeSPL set ID c677b35c-0432-4ee5-af57-1f95449c48b6RxCUI 198048, 198049, 198050UNII A4P49JAZ9HUPC 0371209097109, 0371209098052, 0371209099059, 0371209099028, 0371209098106, 0371209098021, 0371209099103
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471209009902 followed by a unit qualifier and the quantity

Package 71209-0099-02. 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 Sep 12, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ofloxacin tablets, USP are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71209-099

What is NDC 71209-099?: 71209-099 is the product NDC for Ofloxacin, Ofloxacin 400 mg/1 tablet, film coated, listed with the FDA by Cadila Pharmaceuticals Limited. It has 3 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?: Cadila Pharmaceuticals Limited, NDC labeler code 71209. 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
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 400 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-074	72241-0074-0272241-0074-0572241-0074-10
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
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-142	65145-0142-01
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-141	65145-0141-01
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 72 Ofloxacin NDCs

Other NDCs under ANDA 091656

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

FDA NDC Directory listings under ANDA 091656
Product	Strength	Form · route	Labeler	Product NDC
Ofloxacin	Ofloxacin 200 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-097
Ofloxacin	Ofloxacin 300 mg/1	Tablet, Film coatedOral	Cadila Pharmaceuticals Limited	71209-098
Ofloxacin	Ofloxacin 200 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-072
Ofloxacin	Ofloxacin 300 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-073
Ofloxacin	Ofloxacin 400 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-074