NDC 0517-0375

Indigo Carmine

Indigo Carmine

Indigo Carmine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Indigotindisulfonate Sodium.

• Product ID: 0517-0375_354b6d2e-c8d2-4fc4-8505-914b64b34166
• NDC: 0517-0375
• Product Type: Human Prescription Drug
• Proprietary Name: Indigo Carmine
• Generic Name: Indigo Carmine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 1990-09-30
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: American Regent, Inc.
• Substance Name: INDIGOTINDISULFONATE SODIUM
• Active Ingredient Strength: 8 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0517-0375-05

5 AMPULE in 1 BOX (0517-0375-05) > 1 mL in 1 AMPULE (0517-0375-01)

• Marketing Start Date: 1990-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0517-0375-05 [00517037505]

Indigo Carmine INJECTION, SOLUTION

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1990-09-30

NDC 0517-0375-10 [00517037510]

Indigo Carmine INJECTION, SOLUTION

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1990-09-30
• Marketing End Date: 2017-03-03

NDC 0517-0375-01 [00517037501]

Indigo Carmine INJECTION, SOLUTION

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-03

Drug Details

Active Ingredients

Ingredient	Strength
INDIGOTINDISULFONATE SODIUM	8 mg/mL

OpenFDA Data

• SPL SET ID: c6f0dfc8-63b1-4bc1-96eb-3cd0c3d5d4c2
• Manufacturer:
  • American Regent, Inc.
• UNII:
  • D3741U8K7L
• UPC Code:
  • 0305170375058

NDC Crossover Matching brand name "Indigo Carmine" or generic name "Indigo Carmine"

NDC	Brand Name	Generic Name
0517-0375	Indigo Carmine	Indigo Carmine
50090-4520	Indigo Carmine	Indigo Carmine