PILOCARPINE HYDROCHLORIDE
Pilocarpine Hydrochloride Ophthalmic Solution USP (Sterile)
Approved
Approval ID
d2ded29a-448d-4c4a-9307-403836a67da4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-368
Application NumberNDA200890
Product Classification
M
Marketing Category
C73594
G
Generic Name
PILOCARPINE HYDROCHLORIDE
Product Specifications
Route of AdministrationCONJUNCTIVAL
Effective DateSeptember 21, 2010
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PILOCARPINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 0WW6D218XJ
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT