NDC 63323-203

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 Fresenius Kabi Usa, Llc. The primary component is Vancomycin Hydrochloride.

• Product ID: 63323-203_2310f91c-9099-4854-b309-e649a52384f9
• NDC: 63323-203
• 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: 2016-08-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA062663
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: VANCOMYCIN HYDROCHLORIDE
• Active Ingredient Strength: 750 mg/15mL
• Pharm Classes: Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-203-26

10 VIAL in 1 TRAY (63323-203-26) > 15 mL in 1 VIAL (63323-203-41)

• Marketing Start Date: 2016-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-203-20 [63323020320]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062663
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-17

NDC 63323-203-01 [63323020301]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062663
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-11

NDC 63323-203-26 [63323020326]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062663
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-17

NDC 63323-203-41 [63323020341]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA062663
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-17

Drug Details

Active Ingredients

Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	750 mg/15mL

OpenFDA Data

• SPL SET ID: f604d399-fded-4f4f-8efe-af558ed07b9d
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 71WO621TJD
• RxNorm Concept Unique ID - RxCUI:
  • 1807518
  • 1807513
  • 1807516

Pharmacological Class

• 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