Prescription drug · ANDA

Ciprofloxacin (ciprofloxacin hydrochloride) NDC 71335-2046

Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2046Add 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
71335-2046-0713352046007 TABLET, FILM COATED in 1 BOTTLE (71335-2046-0)Marketed from Apr 3, 2024
71335-2046-17133520460114 TABLET, FILM COATED in 1 BOTTLE (71335-2046-1)Marketed from Feb 16, 2022
71335-2046-27133520460230 TABLET, FILM COATED in 1 BOTTLE (71335-2046-2)Marketed from Mar 1, 2022
71335-2046-37133520460320 TABLET, FILM COATED in 1 BOTTLE (71335-2046-3)Marketed from Feb 16, 2022
71335-2046-47133520460460 TABLET, FILM COATED in 1 BOTTLE (71335-2046-4)Marketed from Jun 20, 2022
71335-2046-5713352046056 TABLET, FILM COATED in 1 BOTTLE (71335-2046-5)Marketed from May 17, 2022
71335-2046-67133520460610 TABLET, FILM COATED in 1 BOTTLE (71335-2046-6)Marketed from Feb 15, 2022
71335-2046-77133520460728 TABLET, FILM COATED in 1 BOTTLE (71335-2046-7)Marketed from Mar 7, 2022
71335-2046-871335204608100 TABLET, FILM COATED in 1 BOTTLE (71335-2046-8)Marketed from Nov 29, 2022
71335-2046-97133520460940 TABLET, FILM COATED in 1 BOTTLE (71335-2046-9)Marketed from Apr 3, 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
Generic name (nonproprietary)
ciprofloxacin hydrochloride
Active ingredients
Ciprofloxacin hydrochloride — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077859
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 71335-2046_0b577d32-713b-4ad8-b6f0-d54f886c38c3SPL ID 0b577d32-713b-4ad8-b6f0-d54f886c38c3SPL set ID ac87e3c7-1e51-4dd1-8b75-dec6536810e3RxCUI 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

N471335204600 followed by a unit qualifier and the quantity

Package 71335-2046-00. 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)

Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Infectious Diarrhea ( 1.4 ) Typhoid Fever (Enteric Fever) ( 1.5 ) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Chronic Bacterial Prostatitis ( 1.9 ) Lower Respiratory Tract Infections ( 1.10 ) Acute Exacerbation of Chronic Br…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-636
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-520
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0081
Ciprofloxacin HCLCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0192
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralDIRECT RX72189-111
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-860
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5373
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-649
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1024
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-330
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-873
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 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2146
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-159
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-947
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-978
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-976
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-977
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-216

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