Prescription drug · ANDA
Vancomycin Hydrochloride NDC 0121-1032
Vancomycin hydrochloride 125 mg/1 · Capsule · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1032-20 | 0012110322000121103220 | 2 BLISTER PACK in 1 CARTON (0121-1032-20) / 10 CAPSULE in 1 BLISTER PACKMarketed from May 1, 2026 | |
| 0121-1032-50 | 0012110325000121103250 | 50 CAPSULE in 1 BOTTLE (0121-1032-50)Marketed from May 1, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065478
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 0121-1032_1db451d1-f9ef-4e0a-8239-1c740369b64eSPL ID 1db451d1-f9ef-4e0a-8239-1c740369b64eSPL set ID ae6efaaf-37eb-4510-ba71-5f3dc3abdbd3RxCUI 313570, 313571UNII 71WO621TJDUPC 0301211032508
- 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
N400121103220followed by a unit qualifier and the quantityPackage 00121-1032-20. 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 capsule is indicated for the treatment of Clostridioides difficile -associated diarrhea. Vancomycin hydrochloride capsule 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, vancomycin hydrochloride capsule must be given orally for these infections. • Orally administered vancomycin hydrochloride capsule is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiv…
Excerpt only. Read the full label for complete information.
About NDC 0121-1032
- What is NDC 0121-1032?
- 0121-1032 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 125 mg/1 capsule, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vancomycin Hydrochloride.
- What is the active ingredient?
- Vancomycin hydrochloride.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vancomycin Hydrochloride?
- 140 other product NDCs are listed under this name. See all Vancomycin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vancomycin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vancomycin Hydrochloride | Vancomycin hydrochloride 10 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-958 | 68462-0958-10 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 5 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-957 | 68462-0957-05 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-115 | 83634-0115-30 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-114 | 83634-0114-20 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-116 | 83634-0116-30 |
| vancomycin hydrochloride | Vancomycin hydrochloride 125 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-967 | 23155-0967-2523155-0967-78 |
| vancomycin hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-968 | 23155-0968-2523155-0968-78 |
| vancomycin hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-669 | 59651-0669-0359651-0669-55 |
| vancomycin hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-670 | 59651-0670-0359651-0670-55 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/1 | CapsuleOral | PAI Holdings, LLC dba PAI Pharma | 0121-1033 | 00121-1033-2000121-1033-50 |
Other NDCs under ANDA 065478
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/1 | CapsuleOral | PAI Holdings, LLC dba PAI Pharma | 0121-1033 |