Prescription drug · ANDA
Vancomycin Hydrochloride NDC 67877-750
Kit · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-750-58 | 6787707505867877075058 | 1 KIT in 1 CARTON (67877-750-58) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 147 mL in 1 BOTTLE * 3.75 g in 1 BOTTLEMarketed from Aug 1, 2023 | |
| 67877-750-81 | 6787707508167877075081 | 1 KIT in 1 CARTON (67877-750-81) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 147 mL in 1 BOTTLE * 3.75 g in 1 BOTTLEMarketed from Aug 1, 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
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Dosage form
- Kit
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214913
- Marketing start
- Listing expires
- Identifiers
- Product ID 67877-750_fc015767-2010-4750-9eeb-b04fccdc8c7fSPL ID fc015767-2010-4750-9eeb-b04fccdc8c7fSPL set ID b9a7c728-750b-467f-bf61-54dd836dba1bRxCUI 2000127, 2000134UPC 0367877750583, 0367877751580, 0367877750811, 0367877751818
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
N467877075058followed by a unit qualifier and the quantityPackage 67877-0750-58. 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 for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution 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 r…
Excerpt only. Read the full label for complete information.
About NDC 67877-750
- What is NDC 67877-750?
- 67877-750 is the product NDC for Vancomycin Hydrochloride kit, listed with the FDA by Ascend Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vancomycin Hydrochloride.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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?
- 128 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 5 g/100mL | Injection, Powder, Lyophilized, For solutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-957 | 68462-0957-05 |
| 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 750 mg/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-114 | 83634-0114-20 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-115 | 83634-0115-30 |
| 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 125 mg/1 | CapsuleOral | PAI Holdings, LLC dba PAI Pharma | 0121-1032 | 00121-1032-2000121-1032-50 |
Other NDCs under ANDA 214913
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 | — | Kit | Ascend Laboratories, LLC | 67877-751 |