Prescription drug · ANDA
Moxifloxacin Hydrochloride NDC 57237-156
Moxifloxacin hydrochloride 400 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-156-30 | 57237015630 | 30 TABLET, FILM COATED in 1 BOTTLE (57237-156-30)Marketed from Mar 4, 2014 |
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
- Rising Pharma Holdings, Inc.
- 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 57237-156_20ac52fe-93eb-47c8-8bab-37f745f795fbSPL ID 20ac52fe-93eb-47c8-8bab-37f745f795fbSPL set ID f34c08e6-fe74-4de3-9e36-a82c3c1c183bRxCUI 311787UNII C53598599TUPC 0357237156308
- 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
N457237015630followed by a unit qualifier and the quantityPackage 57237-0156-30. 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.
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 | 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 | AvPAK | 50268-576 |
| 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 |
| 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 | A-S Medication Solutions | 50090-7665 |
| 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 | 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 | Bryant Ranch Prepack | 71335-2815 |
| 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 | Bryant Ranch Prepack | 71335-2329 |