Prescription drug · ANDA

ciprofloxacin NDC 54348-662

Ciprofloxacin hydrochloride 250 mg/1 · Tablet · Oral · PharmPak, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)54348-662Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54348-0662Add 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
54348-662-0654348066206543480662061 BOTTLE in 1 BOX (54348-662-06) / 6 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-662-1454348066214543480662141 BOTTLE in 1 BOX (54348-662-14) / 14 TABLET in 1 BOTTLEMarketed from Jul 10, 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)
ciprofloxacin
Generic name (nonproprietary)
ciprofloxacin
Active ingredients
Ciprofloxacin hydrochloride — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PharmPak, Inc.NDC labeler code 54348
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076639
Marketing start
Listing expires
Other FDA classes
Quinolones (Chemical structure)
Identifiers
Product ID 54348-662_ea938405-8d24-fa08-e053-2995a90af8dcSPL ID ea938405-8d24-fa08-e053-2995a90af8dcSPL set ID e2902d14-16bb-46a9-a45a-4f1f9b0ecf4aRxCUI 197511UNII 4BA73M5E37
Pharmacologic class
Quinolone Antimicrobial

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

N454348066206 followed by a unit qualifier and the quantity

Package 54348-0662-06. 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 ) o Acute Exacerbation of Chronic Bronchi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54348-662

What is NDC 54348-662?
54348-662 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 250 mg/1 tablet, listed with the FDA by PharmPak, Inc.. It has 2 package NDCs, 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?
PharmPak, Inc., NDC labeler code 54348. 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?
166 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 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
Ciprofloxacinciprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-229167296-2291-04

All 167 ciprofloxacin NDCs

Other NDCs under ANDA 076639

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

FDA NDC Directory listings under ANDA 076639
ProductStrengthForm · routeLabelerProduct NDC
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7243
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-411
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-412
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-413
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralQPharma, Inc.42708-192
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-410
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-767
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-869
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-1648
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-1649
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralPharmPak, Inc.54348-663
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0193
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralProficient Rx LP63187-017
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralProficient Rx LP63187-142
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralProficient Rx LP63187-990
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-716
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-919
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralCoupler LLC67046-1528
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4122
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4260

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