pilocarpine hydrchloride
Pilocarpine Hydrochloride Tablets
Approved
Approval ID
2a646f09-72e3-4795-8e69-40fb84d04a4f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 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.
pilocarpine hydrchloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2120
Application NumberANDA076746
Product Classification
M
Marketing Category
C73584
G
Generic Name
pilocarpine hydrchloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB