Norgesic
Norgesic (orphenadrine citrate, aspirin and caffeine tablets)
Approved
Approval ID
be2761bc-e537-4039-846a-2ffa3d8b2afc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Galt Pharmaceuticals, LLC
DUNS: 079214973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orphenadrine Citrate, Aspirin and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61825-305
Application NumberANDA075141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate, Aspirin and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (12)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ORPHENADRINE CITRATEActive
Quantity: 25 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB
ASPIRINActive
Quantity: 385 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 30 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB