NDC 0338-0126

MYXREDLIN

Insulin Human

MYXREDLIN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Insulin Human.

• Product ID: 0338-0126_2094d305-e942-4c30-ade2-25f25677ed8b
• NDC: 0338-0126
• Product Type: Human Prescription Drug
• Proprietary Name: MYXREDLIN
• Generic Name: Insulin Human
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-07-12
• Marketing Category: BLA / NDA
• Application Number: BLA208157
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: INSULIN HUMAN
• Active Ingredient Strength: 1 [iU]/mL
• Pharm Classes: Insulin [CS], Insulin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0338-0126-12

12 CONTAINER in 1 CARTON (0338-0126-12) > 100 mL in 1 CONTAINER

• Marketing Start Date: 2019-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-0126-12 [00338012612]

MYXREDLIN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA208157
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-07-12

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN HUMAN	1 [iU]/mL

OpenFDA Data

• SPL SET ID: afca6e80-a802-49fb-a978-5fe28a173001
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • 1Y17CTI5SR
• RxNorm Concept Unique ID - RxCUI:
  • 2179749
  • 2179744

Pharmacological Class

• Insulin [EPC]
• Insulin [CS]

NDC Crossover Matching brand name "MYXREDLIN" or generic name "Insulin Human"

NDC	Brand Name	Generic Name
0338-0126	MYXREDLIN	insulin human
47918-874	Afrezza	Insulin Human
0002-8215	Humulin	Insulin human
0002-8315	Humulin	Insulin human
0002-8501	Humulin	Insulin human
0002-8715	Humulin	Insulin human
0002-8803	Humulin	Insulin human
0002-8805	Humulin	Insulin human
0002-8824	Humulin	Insulin human