Penicillamine
Penicillamine Capsules
Approved
Approval ID
4afb20ee-eb3f-1937-ffa4-5d3228e82688
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Penicillamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4696
Application NumberANDA213310
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (10)
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT