endari

Generic: glutamine

Labeler: emmaus medical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name endari
Generic Name glutamine
Labeler emmaus medical, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

glutamine 5 g/1

Manufacturer
Emmaus Medical, Inc.

Identifiers & Regulatory

Product NDC 42457-420
Product ID 42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208587
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42457420
Hyphenated Format 42457-420

Supplemental Identifiers

RxCUI
1869684 1928941
UNII
0RH81L854J
NUI
N0000175780 M0000922

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name endari (source: ndc)
Generic Name glutamine (source: ndc)
Application Number NDA208587 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 g/1
source: ndc
Packaging
  • 60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)
source: ndc

Packages (1)

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

Ingredients (1)

glutamine (5 g/1)

Linked Drug Pages (1)

Endari ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10f5d160-6687-44d5-a607-6bf69a7312b6", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["0RH81L854J"], "rxcui": ["1869684", "1928941"], "spl_set_id": ["d5a783f4-12ef-4326-8faa-40018e45ba3b"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Emmaus Medical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 PACKET in 1 CARTON (42457-420-60)  / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)", "package_ndc": "42457-420-60", "marketing_start_date": "20170707"}], "brand_name": "Endari", "product_id": "42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "42457-420", "generic_name": "Glutamine", "labeler_name": "Emmaus Medical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Endari", "active_ingredients": [{"name": "GLUTAMINE", "strength": "5 g/1"}], "application_number": "NDA208587", "marketing_category": "NDA", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}