MedPath

Pilocarpine hydrochloride

Pilocarpine Hydrochloride Tablets

Approved
Approval ID

75fb8a60-bdba-4805-9c32-94377d1eb67f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2009

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-3015
Application NumberNDA020237
Product Classification
M
Marketing Category
C73605
G
Generic Name
Pilocarpine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2015
FDA Product Classification

INGREDIENTS (6)

PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/17/2012

IN-5496/S

Rx Only

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Pilocarpine hydrochloride - FDA Drug Approval Details