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Pilocarpine Hydrochloride Ophthalmic

These highlights do not include all the information needed to use PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION 1.25% safely and effectively. See full prescribing information for  PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION 1.25%. PILOCARPINE HYDROCHLORIDE ophthalmic solution 1.25%, for topical ophthalmic use Initial U.S. Approval: 1974

Approved
Approval ID

93e37b61-7b90-4740-b0b4-17d39d3b03f6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 2, 2025

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

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 Code60219-2366
Application NumberANDA217733
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 2, 2025
FDA Product Classification

INGREDIENTS (8)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

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Pilocarpine Hydrochloride Ophthalmic - FDA Drug Approval Details