Prescription drug · ANDA
Moxifloxacin Hydrochloride Tablets, 400 mg NDC 72789-080
Moxifloxacin hydrochloride monohydrate 400 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-080-10 | 7278900801072789008010 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)Marketed from Apr 10, 2020 |
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 Tablets, 400 mg
- Generic name (nonproprietary)
- moxifloxacin hydrochloride tablets, 400 mg
- Active ingredients
- Moxifloxacin hydrochloride monohydrate — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208682
- Marketing start
- Listing expires
- Other FDA classes
- Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 72789-080_40319333-cf76-1664-e063-6294a90ae7e8SPL ID 40319333-cf76-1664-e063-6294a90ae7e8SPL set ID 5c2a9116-d6e4-429e-88bb-bb6bfedac2f0RxCUI 311787UNII B8956S8609UPC 0372789080109
- 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
N472789008010followed by a unit qualifier and the quantityPackage 72789-0080-10. 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 hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections t…
Excerpt only. Read the full label for complete information.
About NDC 72789-080
- What is NDC 72789-080?
- 72789-080 is the product NDC for Moxifloxacin Hydrochloride Tablets, 400 mg, Moxifloxacin hydrochloride monohydrate 400 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Moxifloxacin Hydrochloride Tablets, 400 mg.
- What is the active ingredient?
- Moxifloxacin hydrochloride monohydrate.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 Tablets, 400 mg?
- 2 other product NDCs are listed under this name. See all Moxifloxacin Hydrochloride Tablets, 400 mg 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 Tablets, 400 mg 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 Tablets, 400 mg | Moxifloxacin hydrochloride monohydrate 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4312 | 70518-4312-00 |
| Moxifloxacin Hydrochloride Tablets, 400 mg | Moxifloxacin hydrochloride monohydrate 400 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-001 | 72205-0001-0572205-0001-3072205-0001-31 |
Other NDCs under ANDA 208682
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 Tablets, 400 mg | Moxifloxacin hydrochloride monohydrate 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4312 |
| Moxifloxacin Hydrochloride Tablets, 400 mg | Moxifloxacin hydrochloride monohydrate 400 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-001 |