Penicillamine
Rx Only
Approved
Approval ID
01e79d8f-8c74-4f48-b761-9f225fabf93d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2020
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-146
Application NumberANDA211231
Product Classification
M
Marketing Category
C73584
G
Generic Name
penicillamine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2020
FDA Product Classification
INGREDIENTS (9)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PENICILLAMINEActive
Quantity: 250 mg in 1 1
Code: GNN1DV99GX
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT