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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

NDC Product Code16714-121
Application NumberANDA212377
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 7, 2021
Generic Namepilocarpine hydrochloride

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

NDC Product Code16714-122
Application NumberANDA212377
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 7, 2021
Generic Namepilocarpine hydrochloride

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
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Pilocarpine Hydrochloride - FDA Approval | MedPath