Prescription drug · ANDA
ciprofloxacin NDC 63187-017
Ciprofloxacin hydrochloride 500 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-017-06 | 6318700170663187001706 | 6 TABLET in 1 BOTTLE (63187-017-06)Marketed from Aug 1, 2014 | |
| 63187-017-10 | 6318700171063187001710 | 10 TABLET in 1 BOTTLE (63187-017-10)Marketed from Aug 1, 2014 | |
| 63187-017-14 | 6318700171463187001714 | 14 TABLET in 1 BOTTLE (63187-017-14)Marketed from Aug 1, 2014 | |
| 63187-017-20 | 6318700172063187001720 | 20 TABLET in 1 BOTTLE (63187-017-20)Marketed from Aug 1, 2014 | |
| 63187-017-28 | 6318700172863187001728 | 28 TABLET in 1 BOTTLE (63187-017-28)Marketed from Aug 4, 2016 | |
| 63187-017-30 | 6318700173063187001730 | 30 TABLET in 1 BOTTLE (63187-017-30)Marketed from Aug 1, 2014 | |
| 63187-017-60 | 6318700176063187001760 | 60 TABLET in 1 BOTTLE (63187-017-60)Marketed from Jul 23, 2021 | |
| 63187-017-90 | 6318700179063187001790 | 90 TABLET in 1 BOTTLE (63187-017-90)Marketed from Jul 23, 2021 |
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
- Proficient Rx LPNDC labeler code 63187
- 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 63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745SPL ID 91f426fc-3fc4-4c2f-a56d-10862e54d745SPL set ID fbcd32c0-bcfd-4cc7-8e81-6612bc0cfc45RxCUI 197511, 309309UNII 4BA73M5E37UPC 0363187142100, 0363187017101
- 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
N463187001706followed by a unit qualifier and the quantityPackage 63187-0017-06. 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)
INDICATIONS AND USAGE Ciprofloxacin Tablets USP, 250 mg and 500 mg is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see Error! Hyperlink reference not valid. for specific recommendations. Adult Patients: Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Acute Uncomplicat…
Excerpt only. Read the full label for complete information.
About NDC 63187-017
- What is NDC 63187-017?
- 63187-017 is the product NDC for ciprofloxacin, Ciprofloxacin hydrochloride 500 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 8 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?
- Proficient Rx LP, NDC labeler code 63187. 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 076639
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 500 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0193 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-767 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | Umasuto, LLC | 85293-004 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Umasuto, LLC | 85293-002 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Umasuto, LLC | 85293-003 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-192 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-1648 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-1649 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4122 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-869 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0070 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4260 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | TabletOral | Proficient Rx LP | 63187-142 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-716 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-413 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-411 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-412 |
| ciprofloxacin | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-102 |
| ciprofloxacin | Ciprofloxacin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-919 |
| ciprofloxacin | Ciprofloxacin hydrochloride 750 mg/1 | TabletOral | Proficient Rx LP | 63187-990 |
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