Axert
These highlights do not include all the information needed to use AXERT safely and effectively. See full prescribing information for AXERT. AXERT (almotriptan malate) Tablets for Oral Use Initial U.S. Approval: 2001
Approved
Approval ID
886c13fa-4547-4411-88aa-8e23a7a698f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
almotriptan malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5527
Application NumberNDA021001
Product Classification
M
Marketing Category
C73594
G
Generic Name
almotriptan malate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2012
FDA Product Classification
INGREDIENTS (11)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
powdered celluloseInactive
Code: SMD1X3XO9M
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
almotriptan malateActive
Quantity: 12.5 mg in 1 1
Code: PJP312605E
Classification: ACTIM
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT