What is NDC 70954-852?

70954-852 is the product NDC for Levofloxacin, Levofloxacin 25 mg/mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?

123 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 70954-852 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-852Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0852Add 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
70954-852-10	7095408521070954085210	100 mL in 1 BOTTLE (70954-852-10)Marketed from Mar 26, 2024
70954-852-20	7095408522070954085220	200 mL in 1 BOTTLE (70954-852-20)Marketed from Mar 26, 2024
70954-852-30	7095408523070954085230	480 mL in 1 BOTTLE (70954-852-30)Marketed from Mar 26, 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): Levofloxacin
Generic name (nonproprietary): levofloxacin
Active ingredients: Levofloxacin — 25 mg/mL
Dosage form: Solution
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091678
Marketing start: Mar 26, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 70954-852_b548d9b8-70c9-41d4-8103-41568d50f561SPL ID b548d9b8-70c9-41d4-8103-41568d50f561SPL set ID a894e40b-77e4-439b-b0f8-9a5cc7a1dd90RxCUI 477391UNII 6GNT3Y5LMFUPC 0370954852308, 0370954852100

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

N470954085210 followed by a unit qualifier and the quantity

Package 70954-0852-10. 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 Jun 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Levofloxacin oral solution is 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. Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure (1.7) Plague (1.8) Urinary Tract Infections: Complicated (1.9, 1.10) and Uncomplicated (1.12) A…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-852

What is NDC 70954-852?: 70954-852 is the product NDC for Levofloxacin, Levofloxacin 25 mg/mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?: 123 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 750 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-769	60760-0769-10
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 750 mg/150mL	Injection, SolutionIntravenous	Hospira, Inc	0409-4444	00409-4444-24
Levofloxacin	Levofloxacin 500 mg/100mL	Injection, SolutionIntravenous	Hospira, Inc	0409-3330	00409-3330-24

All 124 Levofloxacin NDCs