Pilocarpine hydrochloride
Pilocarpine Hydrochloride Tablets Rx Only 8292821/0220F
Approved
Approval ID
6f950741-fd3f-4bf7-83b0-f5aa9dbceb76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code68084-928
Application NumberNDA020237
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pilocarpine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (7)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB