NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0192Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0192Add 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
80425-0192-1804250192018042501920120 TABLET, FILM COATED in 1 BOTTLE (80425-0192-1)Marketed from Jun 24, 2024
80425-0192-2804250192028042501920230 TABLET, FILM COATED in 1 BOTTLE (80425-0192-2)Marketed from Jun 24, 2024

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)
Ciprofloxacin HCL
Generic name (nonproprietary)
ciprofloxacin hcl
Active ingredients
Ciprofloxacin hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077859
Marketing start
Marketing end
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 80425-0192_509c72a9-b580-72a3-e063-6394a90ad351SPL ID 509c72a9-b580-72a3-e063-6394a90ad351SPL set ID e237dd23-faf3-1765-e053-2a95a90ae62dRxCUI 309309UNII 4BA73M5E37

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

N480425019201 followed by a unit qualifier and the quantity

Package 80425-0192-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage 1.1 Skin and Skin Structure Infections Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-­susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. 1.2 Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginos…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0192

What is NDC 80425-0192?
80425-0192 is the product NDC for Ciprofloxacin HCL, Ciprofloxacin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ciprofloxacin HCL.
What is the active ingredient?
Ciprofloxacin hydrochloride.
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ciprofloxacin HCL?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 077859

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

FDA NDC Directory listings under ANDA 077859
ProductStrengthForm · routeLabelerProduct NDC
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8630
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralQPharma Inc42708-088
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2146
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3791
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3852
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5373
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-216
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-866
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-867
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-873
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-976
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-860
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-947
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-076
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-077
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-078
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-2291
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8136
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4214
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-636

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