Nimodipine
Nimodipine Capsules For Oral Use Rx only
Approved
Approval ID
e65d5108-22a2-4d87-a78d-15606f3cc9e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
BIONPHARMA INC.
DUNS: 079637826
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 Code69452-209
Application NumberANDA076740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nimodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (11)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NIMODIPINEActive
Quantity: 30 mg in 1 1
Code: 57WA9QZ5WH
Classification: ACTIB