Prescription drug · ANDA
vancomycin hydrochloride NDC 64380-730
Vancomycin hydrochloride 250 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-730-02 | 64380073002 | 2 BLISTER PACK in 1 CARTON (64380-730-02) / 10 CAPSULE in 1 BLISTER PACK (64380-730-01)Marketed from Jan 1, 2026 | |
| 64380-730-03 | 64380073003 | 50 CAPSULE in 1 BOTTLE (64380-730-03)Marketed from Jan 1, 2026 | |
| 64380-730-04 | 64380073004 | 100 CAPSULE in 1 BOTTLE (64380-730-04)Marketed from Jan 1, 2026 |
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/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065490
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 64380-730_b988cf6d-9db2-4a1e-94fc-fc799ca8a1afSPL ID b988cf6d-9db2-4a1e-94fc-fc799ca8a1afSPL set ID fac438bd-e08f-438d-ab64-426fc5c5450eRxCUI 313570, 313571UNII 71WO621TJDUPC 0364380729037
- 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
N464380073002followed by a unit qualifier and the quantityPackage 64380-0730-02. 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 difficil e-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 effec…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065490
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 | Strides Pharma Science Limited | 64380-729 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-858 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-859 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Redpharm Drug | 67296-2290 |