Penicillamine
Penicillamine Capsules, USP
Approved
Approval ID
064fb48d-aa34-4e52-9295-10f2ca4c77dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2022
Manufacturers
FDA
Navinta LLC
DUNS: 130443810
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 Code68475-201
Application NumberANDA214363
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (15)
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT