Prescription drug · ANDA

Ciprofloxacin NDC 63629-3868

Ciprofloxacin hydrochloride 750 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-3868Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-3868Add 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
63629-3868-16362938680120 TABLET, FILM COATED in 1 BOTTLE (63629-3868-1)Marketed from Oct 30, 2008
63629-3868-26362938680228 TABLET, FILM COATED in 1 BOTTLE (63629-3868-2)Marketed from Jun 12, 2009
63629-3868-36362938680314 TABLET, FILM COATED in 1 BOTTLE (63629-3868-3)Marketed from Apr 23, 2013
63629-3868-46362938680430 TABLET, FILM COATED in 1 BOTTLE (63629-3868-4)Marketed from Jul 26, 2011
63629-3868-56362938680560 TABLET, FILM COATED in 1 BOTTLE (63629-3868-5)Marketed from Dec 14, 2010
63629-3868-66362938680610 TABLET, FILM COATED in 1 BOTTLE (63629-3868-6)Marketed from Dec 3, 2013
63629-3868-76362938680790 TABLET, FILM COATED in 1 BOTTLE (63629-3868-7)Marketed from Mar 6, 2023

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 — 750 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076558
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6bSPL ID 8dabad3c-3808-45cc-a58d-127e3a3d6d6bSPL set ID a57066d7-dc2c-d2d0-b003-d9143fcca1c5RxCUI 197512UNII 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

N463629386801 followed by a unit qualifier and the quantity

Package 63629-3868-01. 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 tablets are 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 Exa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076558

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

FDA NDC Directory listings under ANDA 076558
ProductStrengthForm · routeLabelerProduct NDC
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3063
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-086
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralHikma Pharmaceuticals USA Inc.0143-9927
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1867
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralHikma Pharmaceuticals USA Inc.0143-9928
CiprofloxacinCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralHikma Pharmaceuticals USA Inc.0143-9929
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-108
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-118
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-124
CiprofloxacinCiprofloxacin hydrochloride 750 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-125
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-042
CiprofloxacinCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralDirectRx72189-300
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralDirectRx72189-304
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-193
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2837
CiprofloxacinCiprofloxacin hydrochloride 250 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-214

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