MedPath

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 solutionInitial U.S. Approval: 1974

Approved
Approval ID

84428e9a-f486-44d9-ad93-4ea9069a6787

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 26, 2023

Manufacturers
FDA

Somerset Therapeutics, LLC

DUNS: 079947873

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pilocarpine Hydrochloride Ophthalmic Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70069-201
Application NumberANDA210384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride Ophthalmic Solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 26, 2023
FDA Product Classification

INGREDIENTS (8)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Pilocarpine Hydrochloride Ophthalmic Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70069-181
Application NumberANDA210384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride Ophthalmic Solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 26, 2023
FDA Product Classification

INGREDIENTS (9)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Pilocarpine Hydrochloride Ophthalmic Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70069-191
Application NumberANDA210384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride Ophthalmic Solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 26, 2023
FDA Product Classification

INGREDIENTS (8)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Pilocarpine Hydrochloride - FDA Drug Approval Details