almotriptan
These highlights do not include all the information needed to use ALMOTRIPTAN TABLETS safely and effectively. See full prescribing information for ALMOTRIPTAN TABLETS. ALMOTRIPTAN tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
6fa380c4-c885-4743-85bf-88819ae68645
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
almotriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-042
Application NumberANDA205523
Product Classification
M
Marketing Category
C73584
G
Generic Name
almotriptan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (9)
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
almotriptan malateActive
Quantity: 12.5 mg in 1 1
Code: PJP312605E
Classification: ACTIM
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
almotriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-041
Application NumberANDA205523
Product Classification
M
Marketing Category
C73584
G
Generic Name
almotriptan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (9)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
almotriptan malateActive
Quantity: 6.25 mg in 1 1
Code: PJP312605E
Classification: ACTIM
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT