nimodipine
Nimodipine CapsulesFor Oral UseRx only
Approved
Approval ID
a323ebd8-ef1b-439b-93d1-ba73a5b0127d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nimodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-512
Application NumberANDA077811
Product Classification
M
Marketing Category
C73584
G
Generic Name
nimodipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (11)
NIMODIPINEActive
Quantity: 30 mg in 1 1
Code: 57WA9QZ5WH
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT