Prescription drug · NDA
Vancomycin Hydrochloride NDC 0143-9475
Vancomycin hydrochloride 1540 mg/mg · Injection, Powder, For solution · Intravenous, Oral · HIKMA PHARMACEUTICALS USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9475-10 | 0014394751000143947510 | 10 VIAL in 1 PACKAGE (0143-9475-10) / 1540 mg in 1 VIAL (0143-9475-01)Marketed from Aug 13, 2025 |
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 — 1540 mg/mg
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous, Oral
- Labeler
- HIKMA PHARMACEUTICALS USA INC.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210274
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 0143-9475_d17179c5-783a-487a-ab74-fb8ad3eb9c34SPL ID d17179c5-783a-487a-ab74-fb8ad3eb9c34SPL set ID 8eccafe8-40c9-495a-872d-7f45a98ee759RxCUI 1807513, 1807516, 1807518, 2049888, 2049890UNII 71WO621TJDUPC 0301439474104, 0301439475101, 0301439473107
- 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 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400143947510followed by a unit qualifier and the quantityPackage 00143-9475-10. 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 for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection administered intravenously is indicated for the treatment of: o Septicemia ( 1.1 ) o Infective Endocarditis ( 1.2 ) o Skin and Skin Structure Infections ( 1.3 ) o Bone Infections ( 1.4 ) o Lower Respiratory Tract Infections ( 1.5 ) Vancomycin Hydrochloride for Injection administered orally is indicated for the treatment of: o Clostridioides difficile -associated diarrhea ( 1.6 ) o Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) ( 1.7 ) Limitations of Use ( 1.8 ) Van…
Excerpt only. Read the full label for complete information.
About NDC 0143-9475
- What is NDC 0143-9475?
- 0143-9475 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 1540 mg/mg injection, powder, for solution, listed with the FDA by HIKMA PHARMACEUTICALS USA INC.. It has 1 package NDC, 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?
- HIKMA PHARMACEUTICALS USA INC., NDC labeler code 0143. 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 NDA 210274
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 513 mg/mg | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9161 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1025 mg/mg | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9162 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 5.13 g/g | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9163 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 10.25 g/g | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9164 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 769 mg/mg | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9473 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1280 mg/mg | Injection, Powder, For solutionIntravenous, Oral | HIKMA PHARMACEUTICALS USA INC. | 0143-9474 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 10.25 g/g | Injection, Powder, For solutionIntravenous, Oral | Zhejiang Novus Pharma Co., Ltd. | 71467-014 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 750 mg/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-114 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.25 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-115 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 1.5 g/1 | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-116 |