NDC 42658-004

CAPREOMYCIN SULFATE

Capreomycin

CAPREOMYCIN SULFATE is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hisun Pharmaceuticals Usa, Inc.. The primary component is Capreomycin Sulfate.

• Product ID: 42658-004_796f19e4-91f1-0f01-e053-2a91aa0ac585
• NDC: 42658-004
• Product Type: Human Prescription Drug
• Proprietary Name: CAPREOMYCIN SULFATE
• Generic Name: Capreomycin
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204796
• Labeler Name: Hisun Pharmaceuticals USA, Inc.
• Substance Name: CAPREOMYCIN SULFATE
• Active Ingredient Strength: 1 g/1
• Pharm Classes: Antimycobacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42658-004-01

1 VIAL in 1 CARTON (42658-004-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

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

NDC SPL Data Element Entries

NDC 42658-004-01 [42658000401]

CAPREOMYCIN SULFATE INJECTION, POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204796
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-18
• Marketing End Date: 2020-03-13

Drug Details

Active Ingredients

Ingredient	Strength
CAPREOMYCIN SULFATE	1 g/1

OpenFDA Data

• SPL SET ID: 858c59ec-75db-4380-9b23-c9d3c51a39c8
• Manufacturer:
  • Hisun Pharmaceuticals USA, Inc.
• UNII:
  • 9H8D3J7V21
• RxNorm Concept Unique ID - RxCUI:
  • 239208
• UPC Code:
  • 0342658004017

Pharmacological Class

• Antimycobacterial [EPC]

NDC Crossover Matching brand name "CAPREOMYCIN SULFATE" or generic name "Capreomycin"

NDC	Brand Name	Generic Name
42658-004	CAPREOMYCIN SULFATE	Capreomycin
17478-080	CAPASTAT SULFATE	Capreomycin