NDC 42457-420

Endari

Glutamine

Endari is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Emmaus Medical, Inc.. The primary component is Glutamine.

• Product ID: 42457-420_0bfcd3ad-61a2-4a4a-b98c-3fda6c6362d8
• NDC: 42457-420
• Product Type: Human Prescription Drug
• Proprietary Name: Endari
• Generic Name: Glutamine
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-07
• Marketing Category: NDA / NDA
• Application Number: NDA208587
• Labeler Name: Emmaus Medical, Inc.
• Substance Name: GLUTAMINE
• Active Ingredient Strength: 5 g/1
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 42457-420-60

60 PACKET in 1 CARTON (42457-420-60) > 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)

• Marketing Start Date: 2017-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42457-420-60 [42457042060]

Endari POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208587
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-07

NDC 42457-420-01 [42457042001]

Endari POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208587
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-07

Drug Details

Active Ingredients

Ingredient	Strength
GLUTAMINE	5 g/1

OpenFDA Data

• SPL SET ID: d5a783f4-12ef-4326-8faa-40018e45ba3b
• Manufacturer:
  • Emmaus Medical, Inc.
• UNII:
  • 0RH81L854J
• RxNorm Concept Unique ID - RxCUI:
  • 1869684
  • 1928941

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]