FDA.reportPublic FDA data

Baqsimi

Product NDC
0548-8352
11-digit product format
005488352
Labeler code
0548
Product ID
0548-8352_8d3aa4dd-737c-49b4-af0d-fe95e3bee54d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glucagon
Dosage form
POWDER
Route
NASAL
Labeler
Amphastar Pharmaceuticals, Inc.
Application
NDA210134
Marketing category
NDA
Marketing start
2019-07-24
Substance
GLUCAGON
Active strength
3 mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baqsimi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUCAGON3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76LA80IG2G
Rxcui2180666, 2180671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0548-8352-02Baqsimi2 in 1 CARTONPOWDER26
0548-8352-02Baqsimi1 in 1 TUBEPOWDER16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-8352-02EA - Each0548-8352dbdb274e-961e-4ac0-a897-c0a43b53b14a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-8352BAQSIMI (GLUCAGON) POWDER [AMPHASTAR PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20240711_f1f5df9b-872f-44e5-a18f-f0b68e7e9254.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180671baqsimi 3 MG Nasal PowderPSNf1f5df9b-872f-44e5-a18f-f0b68e7e92546
2180666glucagon 3 MG Nasal PowderPSNf1f5df9b-872f-44e5-a18f-f0b68e7e92546
2180671glucagon 3 MG Nasal Powder [Baqsimi]SBDf1f5df9b-872f-44e5-a18f-f0b68e7e92546
2180666glucagon 3 MG Nasal PowderSCDf1f5df9b-872f-44e5-a18f-f0b68e7e92546
2180671Baqsimi 3 MG Nasal PowderSYf1f5df9b-872f-44e5-a18f-f0b68e7e92546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0548-8352-02005488352022 TUBE in 1 CARTON (0548-8352-02) / 1 BOTTLE, UNIT-DOSE in 1 TUBE / 1 POWDER in 1 BOTTLE, UNIT-DOSE2 tube2024-02-07NoNoHistorical