Prescription drug · ANDA

Ciprofloxacin NDC 67296-1848

Ciprofloxacin hydrochloride 500 mg/1 · Tablet, Coated · Oral · Redpharm Drug

NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1848Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1848Add 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
67296-1848-1672961848016729618480110 TABLET, COATED in 1 BOTTLE (67296-1848-1)Marketed from Aug 12, 2020

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
Active ingredients
Ciprofloxacin hydrochloride — 500 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208921
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 67296-1848_2c62ea96-679a-d05f-e063-6394a90aa2d8SPL ID 2c62ea96-679a-d05f-e063-6394a90aa2d8SPL set ID 17435f05-f04d-e792-e063-6294a90af145RxCUI 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

N467296184801 followed by a unit qualifier and the quantity

Package 67296-1848-01. 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)

Ciprofloxacin 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67296-1848

What is NDC 67296-1848?
67296-1848 is the product NDC for Ciprofloxacin, Ciprofloxacin hydrochloride 500 mg/1 tablet, coated, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ciprofloxacin.
What is the active ingredient?
Ciprofloxacin hydrochloride.
Who is the labeler?
Redpharm Drug, NDC labeler code 67296. 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?
167 other product NDCs are listed under this name. See all Ciprofloxacin 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 Ciprofloxacin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-94760687-0947-01
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-10282868-0102-0682868-0102-1482868-0102-20
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-019355154-0193-00
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralDirect_Rx72189-62772189-0627-1072189-0627-14
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-887568788-8875-0068788-8875-0168788-8875-02+4 more
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralDirect_Rx72189-62372189-0623-1072189-0623-1472189-0623-20
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-69060760-0690-10
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-229167296-2291-04
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-863000615-8630-1000615-8630-1400615-8630-20
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-97659651-0976-0159651-0976-2059651-0976-30+1 more

All 168 Ciprofloxacin NDCs

Other NDCs under ANDA 208921

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

FDA NDC Directory listings under ANDA 208921
ProductStrengthForm · routeLabelerProduct NDC
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-2383
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-2384
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceutical, Inc.68071-3737
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-2450
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, CoatedOralNuCare Pharmaceuticals,Inc.68071-2404
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralA-S Medication Solutions50090-7297
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8692
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralREMEDYREPACK INC.70518-4133
Ciprofloxacinciprofloxacin tabletsCiprofloxacin hydrochloride 250 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-1152
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, CoatedOralProficient Rx LP71205-749
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralBryant Ranch Prepack71335-2502
Ciprofloxacinciprofloxacin tabletsCiprofloxacin hydrochloride 500 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-1229
Ciprofloxacinciprofloxacin tabletsCiprofloxacin hydrochloride 250 mg/1Tablet, CoatedOralYiling Pharmaceutical, Inc.69117-0008
Ciprofloxacinciprofloxacin tabletsCiprofloxacin hydrochloride 500 mg/1Tablet, CoatedOralYiling Pharmaceutical, Inc.69117-0009
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralProficient Rx LP82804-256
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 250 mg/1TabletOralCoupler LLC67046-1460
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, CoatedOralDirect Rx72189-323
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-4229
CiprofloxacinciprofolxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3610
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, CoatedOralSt. Mary's Medical Park Pharmacy60760-676

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