Reyvow
These highlights do not include all the information needed to use REYVOW safely and effectively. See full prescribing information for REYVOW. REYVOW (lasmiditan) tablets, for oral use, CV Initial U.S. Approval: 2020
Approved
Approval ID
aea3358c-ff41-4490-9e6d-c7bf7b3de13f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2022
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lasmiditan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-4491
Application NumberNDA211280
Product Classification
M
Marketing Category
C73594
G
Generic Name
lasmiditan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification
INGREDIENTS (12)
lasmiditanActive
Quantity: 100 mg in 1 1
Code: 760I9WM792
Classification: ACTIB
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
lasmiditan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-4312
Application NumberNDA211280
Product Classification
M
Marketing Category
C73594
G
Generic Name
lasmiditan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2022
FDA Product Classification
INGREDIENTS (11)
lasmiditanActive
Quantity: 50 mg in 1 1
Code: 760I9WM792
Classification: ACTIB
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT