NDC 0049-0024

UNASYN

Ampicillin Sodium And Sulbactam Sodium

UNASYN is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Ampicillin Sodium; Sulbactam Sodium.

• Product ID: 0049-0024_1d3ff5dc-20a7-4ddb-a065-1167e73bf96e
• NDC: 0049-0024
• Product Type: Human Prescription Drug
• Proprietary Name: UNASYN
• Generic Name: Ampicillin Sodium And Sulbactam Sodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 1991-11-22
• Marketing Category: NDA / NDA
• Application Number: NDA050608
• Labeler Name: Roerig
• Substance Name: AMPICILLIN SODIUM; SULBACTAM SODIUM
• Active Ingredient Strength: 100 mg/mL; mg/mL
• Pharm Classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0049-0024-28

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

• Marketing Start Date: 1991-11-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-0024-28 [00049002428]

UNASYN INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1991-11-22

Drug Details

Active Ingredients

Ingredient	Strength
AMPICILLIN SODIUM	100 mg/mL

OpenFDA Data

• SPL SET ID: 12eeb72a-403d-41be-bae4-4cb930862884
• Manufacturer:
  • Roerig
• UNII:
  • DKQ4T82YE6
  • JFN36L5S8K
• RxNorm Concept Unique ID - RxCUI:
  • 240984
  • 205843

Pharmacological Class

• Penicillin-class Antibacterial [EPC]
• Penicillins [CS]
• beta Lactamase Inhibitor [EPC]
• beta Lactamase Inhibitors [MoA]

NDC Crossover Matching brand name "UNASYN" or generic name "Ampicillin Sodium And Sulbactam Sodium"

NDC	Brand Name	Generic Name
0049-0013	UNASYN	ampicillin sodium and sulbactam sodium
0049-0014	UNASYN	ampicillin sodium and sulbactam sodium
0049-0022	UNASYN	ampicillin sodium and sulbactam sodium
0049-0023	UNASYN	ampicillin sodium and sulbactam sodium
0049-0024	UNASYN	ampicillin sodium and sulbactam sodium
0409-2689	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
0409-2987	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
0781-3032	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
0781-3033	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
0781-3034	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
25021-186	ampicillin and sulbactam	ampicillin sodium and sulbactam sodium
25021-187	ampicillin and sulbactam	ampicillin sodium and sulbactam sodium
25021-188	ampicillin and sulbactam	ampicillin sodium and sulbactam sodium
36000-094	Ampicillin and Sulbactam	Ampicillin sodium and sulbactam sodium
36000-095	Ampicillin and Sulbactam	Ampicillin sodium and sulbactam sodium
43858-133	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
43858-134	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium
55150-116	Ampicillin and Sulbactam	Ampicillin Sodium and Sulbactam Sodium