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Pilocarpine Hydrochloride

These highlights do not include all the information needed to use PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION. PILOCARPINE hydrochloride ophthalmic solution Initial U.S. Approval: 1974

Approved
Approval ID

1e87a81a-7084-4436-918b-a50451534307

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2021

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Products 3

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 Code69238-1746
Application NumberANDA214193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (8)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Pilocarpine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1745
Application NumberANDA214193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (9)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Pilocarpine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1747
Application NumberANDA214193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 30, 2023
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYPROMELLOSE 2910 (10000 MPA.S)Inactive
Code: 0HO1H52958
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Pilocarpine Hydrochloride - FDA Drug Approval Details