Penicillamine
Penicillamine Capsules
Approved
Approval ID
51f2790b-41e0-4d84-93cc-654f21b9f38f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2112
Application NumberANDA213310
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT