Prescription drug · ANDA

ciprofloxacin NDC 43063-869

Ciprofloxacin hydrochloride 500 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)43063-869Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0869Add 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
43063-869-0643063086906430630869066 TABLET in 1 BOTTLE, PLASTIC (43063-869-06)Marketed from Aug 4, 2018
43063-869-0843063086908430630869088 TABLET in 1 BOTTLE, PLASTIC (43063-869-08)Marketed from Jul 11, 2018
43063-869-10430630869104306308691010 TABLET in 1 BOTTLE, PLASTIC (43063-869-10)Marketed from Aug 22, 2018
43063-869-20430630869204306308692020 TABLET in 1 BOTTLE, PLASTIC (43063-869-20)Marketed from Aug 17, 2018
43063-869-30430630869304306308693030 TABLET in 1 BOTTLE, PLASTIC (43063-869-30)Marketed from Aug 17, 2018

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 — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076639
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 43063-869_36c1922f-56d3-9a55-e063-6294a90a5571SPL ID 36c1922f-56d3-9a55-e063-6294a90a5571SPL set ID e81341c6-0e25-4860-adda-2d3cebe88d62RxCUI 309309UNII 4BA73M5E37UPC 0343063869307

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

N443063086906 followed by a unit qualifier and the quantity

Package 43063-0869-06. 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 43063-869

What is NDC 43063-869?
43063-869 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 500 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 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 coatedOralCardinal Health 107, LLC55154-0193
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-767
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralUmasuto, LLC85293-004
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralUmasuto, LLC85293-002
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralUmasuto, LLC85293-003
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralProficient Rx LP63187-017
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralQPharma, Inc.42708-192
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-1648
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-1649
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4122
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-0070
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4260
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralProficient Rx LP63187-142
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-716
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-413
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 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-102
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-919
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralProficient Rx LP63187-990

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