What is NDC 61919-426?

61919-426 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 3 package NDCs, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Levofloxacin?

120 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levofloxacin NDC 61919-426 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-426Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0426Add 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
61919-426-07	6191904260761919042607	7 TABLET, FILM COATED in 1 BOTTLE (61919-426-07)Marketed from Apr 24, 2019
61919-426-10	6191904261061919042610	10 TABLET, FILM COATED in 1 BOTTLE (61919-426-10)Marketed from Apr 24, 2019
61919-426-14	6191904261461919042614	14 TABLET, FILM COATED in 1 BOTTLE (61919-426-14)Marketed from Apr 24, 2019

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): Levofloxacin
Generic name (nonproprietary): levofloxacin
Active ingredients: Levofloxacin — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: DIRECT RXNDC labeler code 61919
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202801
Marketing start: Apr 24, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 61919-426_4f5b83f6-1a34-21ec-e063-6294a90a4560SPL ID 4f5b83f6-1a34-21ec-e063-6294a90a4560SPL set ID 4f40d5fa-ebcc-516c-e054-00144ff8d46cRxCUI 199885, 311296UNII 6GNT3Y5LMF

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

N461919042607 followed by a unit qualifier and the quantity

Package 61919-0426-07. 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 Apr 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 1.1 Nosocomial Pneumonia Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-426

What is NDC 61919-426?: 61919-426 is the product NDC for Levofloxacin, Levofloxacin 500 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levofloxacin.
What is the active ingredient?: Levofloxacin.
Who is the labeler?: DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levofloxacin?: 120 other product NDCs are listed under this name. See all Levofloxacin 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 Levofloxacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1358	67046-1358-03
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4568	70518-4568-00
levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1078	67046-1078-03
levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc	68788-8809	68788-8809-0168788-8809-0268788-8809-04+1 more
levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8772	68788-8772-0168788-8772-0268788-8772-03+2 more
Levofloxacinllevofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0388	80425-0388-0180425-0388-02
Levofloxacin	Levofloxacin 250 mg/50mL	Injection, SolutionIntravenous	Hospira, Inc	0409-2220	00409-2220-24
Levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Hospira, Inc	0409-3330	00409-3330-24
Levofloxacin	Levofloxacin 750 mg/150mL	Injection, SolutionIntravenous	Hospira, Inc	0409-4444	00409-4444-24
Levofloxacin	Levofloxacin 25 mg/mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-852	70954-0852-1070954-0852-2070954-0852-30

All 121 Levofloxacin NDCs

Other NDCs under ANDA 202801

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

FDA NDC Directory listings under ANDA 202801
Product	Strength	Form · route	Labeler	Product NDC
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0587
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3245
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3311
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-1860
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3314
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0794
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	VERITYRX, LLC	83939-0020
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4512
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0719
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	DirectRx	72189-338
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3093
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3218
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0968
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-002
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-769
Levofloxacin	Levofloxacin 750 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-248
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4738
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	ADVANCED RX PHARMACY OF TENNESSEE, LLC	80425-0007
Levofloxacin	Levofloxacin 250 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-721
Levofloxacin	Levofloxacin 500 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-722

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