Prescription drug · ANDA

ciprofloxacin NDC 63187-990

Ciprofloxacin hydrochloride 750 mg/1 · Tablet · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-990Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0990Add 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
63187-990-06631870990066 TABLET in 1 BOTTLE (63187-990-06)Marketed from Mar 1, 2018
63187-990-07631870990077 TABLET in 1 BOTTLE (63187-990-07)Marketed from Mar 1, 2018
63187-990-106318709901010 TABLET in 1 BOTTLE (63187-990-10)Marketed from Mar 1, 2018
63187-990-146318709901414 TABLET in 1 BOTTLE (63187-990-14)Marketed from Mar 1, 2018
63187-990-286318709902828 TABLET in 1 BOTTLE (63187-990-28)Marketed from Mar 1, 2018
63187-990-306318709903030 TABLET in 1 BOTTLE (63187-990-30)Marketed from Mar 1, 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 — 750 mg/1
Dosage form
Tablet
Route
Oral
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 63187-990_d0f31dff-c2dd-487d-a329-342765d135e3SPL ID d0f31dff-c2dd-487d-a329-342765d135e3SPL set ID 4af3894a-8945-4b2d-bdf6-a83bbd415b89RxCUI 197512UNII 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

N463187099006 followed by a unit qualifier and the quantity

Package 63187-0990-06. 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 Exacerbatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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/1TabletOralNuCare Pharmaceuticals, Inc.66267-716
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-919
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralQPharma, Inc.42708-192
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-869
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralBryant Ranch Prepack71335-0408
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralCoupler LLC67046-1528
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-413
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralPharmPak, Inc.54348-662
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 500 mg/1TabletOralPharmPak, Inc.54348-663
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0193
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-410
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralUmasuto, LLC85293-003
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1TabletOralUmasuto, LLC85293-002
ciprofloxacinCiprofloxacin hydrochloride 750 mg/1TabletOralUmasuto, LLC85293-004
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-0070
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralProficient Rx LP63187-017
ciprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-102
ciprofloxacinCiprofloxacin hydrochloride 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4122

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