Prescription drug · NDA
Cipro (Ciprofloxacin) NDC 50419-773
Kit · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-773-01 | 50419077301 | 1 KIT in 1 KIT (50419-773-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, GLASSMarketed from Sep 26, 1997 |
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)
- Cipro
- Generic name (nonproprietary)
- ciprofloxacin
- Dosage form
- Kit
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020780
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-773_1b112839-6cf0-466a-9188-86fc5b1549f9SPL ID 1b112839-6cf0-466a-9188-86fc5b1549f9SPL set ID 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0RxCUI 197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310UNII 4BA73M5E37UPC 0350419754019, 0350419758017
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450419077301followed by a unit qualifier and the quantityPackage 50419-0773-01. 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)
CIPRO 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 ) • Acute Exacerbation of Chro…
Excerpt only. Read the full label for complete information.
About NDC 50419-773
- What is NDC 50419-773?
- 50419-773 is the product NDC for Cipro (ciprofloxacin) kit, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cipro (Ciprofloxacin).
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cipro?
- 3 other product NDCs are listed under this name. See all Cipro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cipro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprociprofloxacin | — | Kit | Bayer HealthCare Pharmaceuticals Inc. | 50419-777 | 50419-0777-01 |
| Ciprociprofloxacin hydrochloride | Ciprofloxacin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-754 | 50419-0754-01 |
| Ciprociprofloxacin hydrochloride | Ciprofloxacin hydrochloride 250 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-758 | 50419-0758-01 |
Other NDCs under NDA 020780
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 |
|---|---|---|---|---|
| Ciprociprofloxacin | — | Kit | Bayer HealthCare Pharmaceuticals Inc. | 50419-777 |