NDC 67457-822

Vancomycin Hydrochloride

Vancomycin Hydrochloride

Vancomycin Hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Vancomycin Hydrochloride.

• Product ID: 67457-822_299d6633-50ef-416b-b322-91a2d2d1b859
• NDC: 67457-822
• Product Type: Human Prescription Drug
• Proprietary Name: Vancomycin Hydrochloride
• Generic Name: Vancomycin Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA209481
• Labeler Name: Mylan Institutional LLC
• Substance Name: VANCOMYCIN HYDROCHLORIDE
• Active Ingredient Strength: 250 mg/5mL
• Pharm Classes: Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67457-822-99

10 VIAL, SINGLE-DOSE in 1 CARTON (67457-822-99) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-822-25)

• Marketing Start Date: 2018-08-31
• Marketing End Date: 2022-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-822-25 [67457082225]

Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209481
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-31

NDC 67457-822-99 [67457082299]

Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209481
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-31

Drug Details

Active Ingredients

Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	250 mg/5mL

OpenFDA Data

• SPL SET ID: caf22ccb-df75-45ea-a1d0-ccb2d37272fb
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 71WO621TJD
• RxNorm Concept Unique ID - RxCUI:
  • 2049891
  • 1807518
  • 2049888
  • 2049890

Pharmacological Class

• Glycopeptide Antibacterial [EPC]
• Glycopeptides [CS]
• Glycopeptide Antibacterial [EPC]
• Glycopeptides [CS]

NDC Crossover Matching brand name "Vancomycin Hydrochloride" or generic name "Vancomycin Hydrochloride"

NDC	Brand Name	Generic Name
0121-0867	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
0121-0890	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
0143-9355	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0143-9356	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0143-9357	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0143-9358	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0143-9359	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
0409-4332	Vancomycin Hydrochloride	Vancomycin Hydrochloride
68001-338	Vancomycin Hydrochloride	Vancomycin Hydrochloride
68001-339	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6535	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6509	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6533	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6534	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6531	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0409-6510	Vancomycin Hydrochloride	Vancomycin Hydrochloride
68083-143	Vancomycin Hydrochloride	Vancomycin Hydrochloride
68083-144	Vancomycin Hydrochloride	Vancomycin Hydrochloride
68180-166	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
68180-167	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
70594-046	Vancomycin Hydrochloride	Vancomycin Hydrochloride
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride
70594-045	Vancomycin Hydrochloride	Vancomycin Hydrochloride
70860-105	Vancomycin Hydrochloride	Vancomycin Hydrochloride
70860-104	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0781-3188	Vancomycin Hydrochloride	Vancomycin Hydrochloride
0781-3187	Vancomycin Hydrochloride	Vancomycin Hydrochloride
17478-741	Vancomycin Hydrochloride	Vancomycin Hydrochloride
17478-742	Vancomycin Hydrochloride	Vancomycin Hydrochloride
23155-218	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
23155-219	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
23155-217	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
45932-0032	Vancomycin Hydrochloride	Vancomycin Hydrochloride
45932-0029	Vancomycin Hydrochloride	Vancomycin Hydrochloride
45932-0031	Vancomycin Hydrochloride	Vancomycin Hydrochloride
47781-729	vancomycin hydrochloride	vancomycin hydrochloride
47781-730	vancomycin hydrochloride	vancomycin hydrochloride
45932-0028	Vancomycin Hydrochloride	Vancomycin Hydrochloride
47781-597	Vancomycin Hydrochloride	Vancomycin Hydrochloride
47781-598	Vancomycin Hydrochloride	Vancomycin Hydrochloride
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride
51991-940	Vancomycin Hydrochloride	Vancomycin Hydrochloride
51991-941	Vancomycin Hydrochloride	Vancomycin Hydrochloride
55150-204	Vancomycin Hydrochloride	Vancomycin Hydrochloride
55150-203	Vancomycin Hydrochloride	Vancomycin Hydrochloride
55150-205	Vancomycin Hydrochloride	Vancomycin Hydrochloride
55150-206	Vancomycin Hydrochloride	Vancomycin Hydrochloride