NDC 70594-045

Vancomycin Hydrochloride

Vancomycin Hydrochloride

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

• Product ID: 70594-045_601fc8cd-0d63-46c7-8b51-ef7d36608394
• NDC: 70594-045
• Product Type: Human Prescription Drug
• Proprietary Name: Vancomycin Hydrochloride
• Generic Name: Vancomycin Hydrochloride
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-01-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204107
• Labeler Name: Xellia Pharmaceuticals USA LLC
• Substance Name: VANCOMYCIN HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70594-045-02

10 VIAL, GLASS in 1 CARTON (70594-045-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-045-01)

• Marketing Start Date: 2019-01-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70594-045-03 [70594004503]

Vancomycin Hydrochloride INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-28

NDC 70594-045-02 [70594004502]

Vancomycin Hydrochloride INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-28

NDC 70594-045-01 [70594004501]

Vancomycin Hydrochloride INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204107
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-28

Drug Details

Active Ingredients

Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 7e416822-15cf-4749-9599-2c9710e1674c
• Manufacturer:
  • Xellia Pharmaceuticals USA LLC
• UNII:
  • 71WO621TJD
• RxNorm Concept Unique ID - RxCUI:
  • 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