out AXERT that is written for health professionals.
What are the ingredients in AXERT?
Active ingredient: almotriptan malate
Inactive ingredients: carnauba wax, cellulose, FD&C Blue No. 2 (12.5 mg only), hypromellose, iron oxide (6.25 mg only), mannitol, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide.
Manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778
AXERT® Tablets are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
Licensed from: Almirall, S.A.
For more information, go to www.AXERT.com or call 1-800-526-7736.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 6.25 mg Tablet Carton
NDC 50458-211-01
Axert®
(almotriptan malate) Tablets
equivalent to
6.25 mg
almotriptan
6 tablets
Rx only
Janssen
PRINCIPAL DISPLAY PANEL - 6.25 mg Tablet Carton
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton
NDC 50458-210-01
Axert®
(almotriptan malate) Tablets
equivalent to
12.5 mg
almotriptan
12 tablets
Rx only
Janssen
PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton
CLOSE
INGREDIENTS AND APPEARANCE
AXERT
almotriptan malate tablet, coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-211
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
almotriptan malate (UNII: PJP312605E) (almotriptan - UNII:1O4XL5SN61) almotriptan 6.25 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
mannitol (UNII: 3OWL53L36A)
powdered cellulose (UNII: SMD1X3XO9M)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
sodium starch glycolate type A potato (UNII: 5856J3G2A2)
sodium stearyl fumarate (UNII: 7CV7WJK4UI)
titanium dioxide (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
propylene glycol (UNII: 6DC9Q167V3)
ferric oxide red (UNII: 1K09F3G675)
carnauba wax (UNII: R12CBM0EIZ)
PRODUCT CHARACTERISTICS
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 2080
Contains
PACKAGING
Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50458-211-01 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/07/2001
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021001 05/07/2001
AXERT
almotriptan malate tablet, coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-210
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
almotriptan malate (UNII: PJP312605E) (almotriptan - UNII:1O4XL5SN61) almotriptan 12.5 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
mannitol (UNII: 3OWL53L36A)
powdered cellulose (UNII: SMD1X3XO9M)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
sodium |
