Prescription drug · NDA AUTHORIZED GENERIC
Vancomycin Hydrochloride for Oral Solution (Vancomycin hydrochloride) NDC 52536-108
Kit · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-108-10 | 5253601081052536010810 | 1 KIT in 1 CARTON (52536-108-10) * 15 g in 1 BOTTLE (52536-098-10) * 289 mL in 1 BOTTLE (52536-088-10)Marketed from Mar 31, 2023 |
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 for Oral Solution
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Dosage form
- Kit
- Labeler
- Wilshire Pharmaceuticals, Inc.NDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 208910
- Marketing start
- Listing expires
- Identifiers
- Product ID 52536-108_5693f5ad-555a-1e14-e063-6294a90a1f43SPL ID 5693f5ad-555a-1e14-e063-6294a90a1f43SPL set ID 4c3d2e99-5351-4442-916a-d2001b0a5f5aRxCUI 2000127, 2000134
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N452536010810followed by a unit qualifier and the quantityPackage 52536-0108-10. 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 is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant…
Excerpt only. Read the full label for complete information.
About NDC 52536-108
- What is NDC 52536-108?
- 52536-108 is the product NDC for Vancomycin Hydrochloride for Oral Solution kit, listed with the FDA by Wilshire Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vancomycin Hydrochloride for Oral Solution (Vancomycin hydrochloride).
- Who is the labeler?
- Wilshire Pharmaceuticals, Inc., NDC labeler code 52536. 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 for Oral Solution?
- 3 other product NDCs are listed under this name. See all Vancomycin Hydrochloride for Oral Solution 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 for Oral Solution 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 for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-104 | 52536-0104-05 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-106 | 52536-0106-05 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-107 | 52536-0107-10 |
Other NDCs under NDA 208910
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 |
|---|---|---|---|---|
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-204 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-205 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-206 |
| Firvanqvancomycin hydrochloride | — | Kit | Azurity Pharmaceuticals, Inc | 65628-208 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-104 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-106 |
| Vancomycin Hydrochloride for Oral Solutionvancomycin hydrochloride | — | Kit | Wilshire Pharmaceuticals, Inc. | 52536-107 |