Prescription drug · ANDA
Ciprofloxacin NDC 63629-3868
Ciprofloxacin hydrochloride 750 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3868-1 | 6362938680163629386801 | 20 TABLET, FILM COATED in 1 BOTTLE (63629-3868-1)Marketed from Oct 30, 2008 | |
| 63629-3868-2 | 6362938680263629386802 | 28 TABLET, FILM COATED in 1 BOTTLE (63629-3868-2)Marketed from Jun 12, 2009 | |
| 63629-3868-3 | 6362938680363629386803 | 14 TABLET, FILM COATED in 1 BOTTLE (63629-3868-3)Marketed from Apr 23, 2013 | |
| 63629-3868-4 | 6362938680463629386804 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-3868-4)Marketed from Jul 26, 2011 | |
| 63629-3868-5 | 6362938680563629386805 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-3868-5)Marketed from Dec 14, 2010 | |
| 63629-3868-6 | 6362938680663629386806 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-3868-6)Marketed from Dec 3, 2013 | |
| 63629-3868-7 | 6362938680763629386807 | 90 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
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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
- Pharmacologic class
- Fluoroquinolone Antibacterial
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
N463629386801followed by a unit qualifier and the quantityPackage 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.
About NDC 63629-3868
- What is NDC 63629-3868?
- 63629-3868 is the product NDC for Ciprofloxacin, Ciprofloxacin hydrochloride 750 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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.
Related NDCs: other Ciprofloxacin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-947 | 60687-0947-01 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-102 | 82868-0102-0682868-0102-1482868-0102-20 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0193 | 55154-0193-00 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-627 | 72189-0627-1072189-0627-14 |
| Ciprofloxacinciprofolxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8875 | 68788-8875-0068788-8875-0168788-8875-02+4 more |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-623 | 72189-0623-1072189-0623-1472189-0623-20 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-690 | 60760-0690-10 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2291 | 67296-2291-04 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8630 | 00615-8630-1000615-8630-1400615-8630-20 |
| Ciprofloxacinciprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-976 | 59651-0976-0159651-0976-2059651-0976-30+1 more |
Other NDCs under ANDA 076558
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1867 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-108 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-118 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-124 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-125 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2837 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-300 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-304 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3063 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-193 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-042 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-214 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9928 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-086 |
| Ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0143-9929 |