Prescription drug · ANDA
Vancomycin Hydrochloride NDC 62559-830
Vancomycin hydrochloride 250 mg/5mL · Powder, For solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-830-03 | 62559083003 | 300 mL in 1 BOTTLE, PLASTIC (62559-830-03)Marketed from Sep 9, 2019 | |
| 62559-830-55 | 62559083055 | 150 mL in 1 BOTTLE, PLASTIC (62559-830-55)Marketed from Sep 9, 2019 | |
| 62559-830-80 | 62559083080 | 80 mL in 1 BOTTLE, PLASTIC (62559-830-80)Marketed from Sep 9, 2019 |
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)
- Vancomycin Hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 250 mg/5mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061667
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 62559-830_c02af1aa-0e2c-4174-9349-8838710838eeSPL ID c02af1aa-0e2c-4174-9349-8838710838eeSPL set ID 27d06545-1af0-4dcd-926d-58d4a9492ec3RxCUI 2000134UNII 71WO621TJDUPC 0362559830805
- Pharmacologic class
- Glycopeptide 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
N462559083003followed by a unit qualifier and the quantityPackage 62559-0830-03. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile . Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 061667
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 |
|---|---|---|---|---|
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 72162-1775 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 71335-2950 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 71335-2948 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 63629-1970 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 63629-1971 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 63629-1972 |