Pilocarpine Hydrochloride
Pilocarpine Hydrochloride Tablets, USP Rx only
Approved
Approval ID
90c31478-4bd5-43bb-9287-d014b62c3b3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2022
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 2
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 Code16714-121
Application NumberANDA212377
Product Classification
M
Marketing Category
C73584
G
Generic Name
pilocarpine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2021
FDA Product Classification
INGREDIENTS (6)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
pilocarpine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-122
Application NumberANDA212377
Product Classification
M
Marketing Category
C73584
G
Generic Name
pilocarpine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2021
FDA Product Classification
INGREDIENTS (7)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT