Prescription drug · NDA
Vancocin (vancomycin hydrochloride) NDC 62559-311
Vancomycin hydrochloride 250 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-311-20 | 62559031120 | 2 BLISTER PACK in 1 CARTON (62559-311-20) / 10 CAPSULE in 1 BLISTER PACKMarketed from Nov 17, 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)
- Vancocin
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Active ingredients
- Vancomycin hydrochloride — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050606
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 62559-311_25ea5560-90e4-4bba-a264-f8fec58bfc6eSPL ID 25ea5560-90e4-4bba-a264-f8fec58bfc6eSPL set ID a078d9c2-f89c-4f9f-8ded-60ffb2983c3fRxCUI 201848, 201849, 313570, 313571UNII 71WO621TJDUPC 0362559310208, 0362559311205
- 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
N462559031120followed by a unit qualifier and the quantityPackage 62559-0311-20. 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)
VANCOCIN is indicated for the treatment of Clostridioides difficil e-associated diarrhea. VANCOCIN is 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, VANCOCIN must be given orally for these infections. • Orally administered VANCOCIN is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN and other antibacterial drugs, VANCOCIN should be used only to treat or preven…
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 125 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-310 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-390 |
| 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 |