Prescription drug · ANDA
Moxifloxacin Hydrochloride NDC 50268-576
Moxifloxacin hydrochloride 400 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-576-13 | 5026805761350268057613 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-576-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11)Marketed from Jul 22, 2016 |
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)
- Moxifloxacin Hydrochloride
- Generic name (nonproprietary)
- moxifloxacin hydrochloride
- Active ingredients
- Moxifloxacin hydrochloride — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202632
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 50268-576_4ee2636f-f50a-98d3-e063-6294a90a7e15SPL ID 4ee2636f-f50a-98d3-e063-6294a90a7e15SPL set ID 371ca7b2-c62d-ef4b-3076-890b385bfff8RxCUI 311787UNII C53598599T
- 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
N450268057613followed by a unit qualifier and the quantityPackage 50268-0576-13. 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)
Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: • Community Acquired Pneumonia (1.1) • Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) • Complicated Intra-Abdominal Infections (1.4) • Plague (1.5) • Acute Bacterial Sinusitis (1.6) • Acute Bacterial Exacerbation of Chronic Bronchitis (1.7) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven…
Excerpt only. Read the full label for complete information.
About NDC 50268-576
- What is NDC 50268-576?
- 50268-576 is the product NDC for Moxifloxacin Hydrochloride, Moxifloxacin hydrochloride 400 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin Hydrochloride.
- What is the active ingredient?
- Moxifloxacin hydrochloride.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Moxifloxacin Hydrochloride?
- 19 other product NDCs are listed under this name. See all Moxifloxacin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Moxifloxacin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4458 | 70518-4458-00 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2232 | 67296-2232-03 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-081 | 70069-0081-01 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7407 | 00904-7407-0400904-7407-06 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3738 | 70518-3738-00 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | SolutionOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1410 | 00832-1410-03 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 5 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-331 | 76420-0331-03 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/250mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-323 | 67457-0323-25 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-722 | 68084-0722-65 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6609 | 50090-6609-0050090-6609-01 |
Other NDCs under ANDA 202632
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 |
|---|---|---|---|---|
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7407 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6609 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7244 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7665 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-156 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-603 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-722 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3738 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4458 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2329 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2815 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-037 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-038 |
| Moxifloxacin Hydrochloride | Moxifloxacin hydrochloride 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-350 |