Penicillamine
Penicillamine Capsules, USP Rx Only
Approved
Approval ID
c92335c6-f6fa-4768-9401-55c6b7f87699
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-916
Application NumberANDA211735
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (10)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB