Prescription drug · ANDA
Vancomycin Hydrochloride NDC 63629-1972
Vancomycin hydrochloride 250 mg/5mL · Powder, For solution · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1972-1 | 6362919720163629197201 | 300 mL in 1 BOTTLE (63629-1972-1)Marketed from Sep 9, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/5mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061667
- Marketing start
- Listing expires
- Other FDA classes
- Glycopeptides (Chemical structure)
- Identifiers
- Product ID 63629-1972_16157db2-78ce-4fe6-9cc5-33d433db882bSPL ID 16157db2-78ce-4fe6-9cc5-33d433db882bSPL set ID a09c589b-e7f4-457c-827f-e1bfa1b26700RxCUI 2000134UNII 71WO621TJD
- 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
N463629197201followed by a unit qualifier and the quantityPackage 63629-1972-01. 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)
INDICATIONS AND USAGE Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile . Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other …
Excerpt only. Read the full label for complete information.
About NDC 63629-1972
- What is NDC 63629-1972?
- 63629-1972 is the product NDC for Vancomycin Hydrochloride, Vancomycin hydrochloride 250 mg/5mL powder, for solution, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 061667
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/5mL | Powder, For solutionOral | ANI Pharmaceuticals, Inc. | 62559-830 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 63629-1970 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 63629-1971 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 71335-2948 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 71335-2950 |
| Vancomycin Hydrochloride | Vancomycin hydrochloride 250 mg/5mL | Powder, For solutionOral | Bryant Ranch Prepack | 72162-1775 |