NDC 61916-135

Bretylium Tosylate

Bretylium Tosylate

Bretylium Tosylate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutics International, Inc. (pii). The primary component is Bretylium Tosylate.

• Product ID: 61916-135_33f1cc11-9657-41b9-b604-6fa2b41e6992
• NDC: 61916-135
• Product Type: Human Prescription Drug
• Proprietary Name: Bretylium Tosylate
• Generic Name: Bretylium Tosylate
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204386
• Labeler Name: Pharmaceutics International, Inc. (Pii)
• Substance Name: BRETYLIUM TOSYLATE
• Active Ingredient Strength: 50 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61916-135-50

5 VIAL, SINGLE-DOSE in 1 CARTON (61916-135-50) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61916-135-50 [61916013550]

Bretylium Tosylate INJECTION

• Marketing Category: ANDA
• Application Number: ANDA204386
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-30
• Marketing End Date: 2020-03-12

Drug Details

Active Ingredients

Ingredient	Strength
BRETYLIUM TOSYLATE	50 mg/mL

OpenFDA Data

• SPL SET ID: 81fb8917-d711-4124-ab23-3ef07adf8be6
• Manufacturer:
  • Pharmaceutics International, Inc. (Pii)
• UNII:
  • 78ZP3YR353
• RxNorm Concept Unique ID - RxCUI:
  • 2176262

NDC Crossover Matching brand name "Bretylium Tosylate" or generic name "Bretylium Tosylate"

NDC	Brand Name	Generic Name
61916-135	Bretylium Tosylate	Bretylium Tosylate
62559-870	Bretylium Tosylate	bretylium tosylate