Prescription drug · NDA AUTHORIZED GENERIC
vancomycin hydrochloride NDC 62559-390
Vancomycin hydrochloride 125 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-390-20 | 62559039020 | 2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 26, 2015 | |
| 62559-390-50 | 62559039050 | 50 CAPSULE in 1 BOTTLE (62559-390-50)Marketed from Dec 20, 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)
- vancomycin hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 050606
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 62559-390_cf20df7a-8689-49f9-a77b-a0a832fea8faSPL ID cf20df7a-8689-49f9-a77b-a0a832fea8faSPL set ID 3707ad2e-5c82-4111-a370-e518e5e7e4c5RxCUI 313570, 313571UNII 71WO621TJD
- 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
N462559039020followed by a unit qualifier and the quantityPackage 62559-0390-20. 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)
Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile -associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections. • Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the e…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 050606
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 125 mg/1 | CapsuleOral | Redpharm Drug | 67296-2143 |
| Vancocinvancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-311 |
| Vancocinvancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-310 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-391 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0514 |