Almotriptan Malate
These highlights do not include all the information needed to use ALMOTRIPTAN MALATE TABLETS safely and effectively. See full prescribing information for ALMOTRIPTAN MALATE TABLETS. ALMOTRIPTAN MALATE tablets, for oral useInitial U.S. Approval: 2001
Approved
Approval ID
c41a4579-9db0-402b-81b1-0adf5b3978c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2017
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
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 Code0093-5260
Application NumberANDA078027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Almotriptan Malate
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
ALMOTRIPTAN MALATEActive
Quantity: 6.25 mg in 1 1
Code: PJP312605E
Classification: ACTIM
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Almotriptan Malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-5261
Application NumberANDA078027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Almotriptan Malate
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALMOTRIPTAN MALATEActive
Quantity: 12.5 mg in 1 1
Code: PJP312605E
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT