Pilocarpine Hydrochloride
Pilocarpine Hydrochloride
Approved
Approval ID
4b856409-ee10-455b-a0f3-69c65df69123
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2019
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pilocarpine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-680
Application NumberANDA076963
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2019
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT