baqsimi

Generic: glucagon

Labeler: amphastar pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name baqsimi
Generic Name glucagon
Labeler amphastar pharmaceuticals, inc.
Dosage Form POWDER
Routes
NASAL
Active Ingredients

glucagon 3 mg/1

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-8351
Product ID 0548-8351_8d3aa4dd-737c-49b4-af0d-fe95e3bee54d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210134
Listing Expiration 2026-12-31
Marketing Start 2019-07-24

Pharmacologic Class

Established (EPC)
antihypoglycemic agent [epc] gastrointestinal motility inhibitor [epc]
Physiologic Effect
increased gluconeogenesis [pe] increased glycogenolysis [pe] decreased gi smooth muscle tone [pe] decreased gi motility [pe] decreased glycolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05488351
Hyphenated Format 0548-8351

Supplemental Identifiers

RxCUI
2180666 2180671
UNII
76LA80IG2G
NUI
N0000190852 N0000190853 N0000009340 N0000009345 N0000008636 N0000008635 N0000008652

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 baqsimi (source: ndc)
Generic Name glucagon (source: ndc)
Application Number NDA210134 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0548-8351-01) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE
source: ndc

Packages (1)

0548-8351-01 1 TUBE in 1 CARTON (0548-8351-01) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE

Ingredients (1)

glucagon (3 mg/1)

Linked Drug Pages (1)

Baqsimi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "8d3aa4dd-737c-49b4-af0d-fe95e3bee54d", "openfda": {"nui": ["N0000190852", "N0000190853", "N0000009340", "N0000009345", "N0000008636", "N0000008635", "N0000008652"], "unii": ["76LA80IG2G"], "rxcui": ["2180666", "2180671"], "spl_set_id": ["f1f5df9b-872f-44e5-a18f-f0b68e7e9254"], "pharm_class_pe": ["Increased Gluconeogenesis [PE]", "Increased Glycogenolysis [PE]", "Decreased GI Smooth Muscle Tone [PE]", "Decreased GI Motility [PE]", "Decreased Glycolysis [PE]"], "pharm_class_epc": ["Antihypoglycemic Agent [EPC]", "Gastrointestinal Motility Inhibitor [EPC]"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0548-8351-01)  / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE", "package_ndc": "0548-8351-01", "marketing_start_date": "20240315"}], "brand_name": "Baqsimi", "product_id": "0548-8351_8d3aa4dd-737c-49b4-af0d-fe95e3bee54d", "dosage_form": "POWDER", "pharm_class": ["Antihypoglycemic Agent [EPC]", "Decreased GI Motility [PE]", "Decreased GI Smooth Muscle Tone [PE]", "Decreased Glycolysis [PE]", "Gastrointestinal Motility Inhibitor [EPC]", "Increased Gluconeogenesis [PE]", "Increased Glycogenolysis [PE]"], "product_ndc": "0548-8351", "generic_name": "glucagon", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baqsimi", "active_ingredients": [{"name": "GLUCAGON", "strength": "3 mg/1"}], "application_number": "NDA210134", "marketing_category": "NDA", "marketing_start_date": "20190724", "listing_expiration_date": "20261231"}