Cromolyn Sodium
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile
Approved
Approval ID
f7a6334c-7b98-4730-8ee6-ca37cf87bba3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cromolyn Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-0140
Application NumberANDA075282
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2018
FDA Product Classification
INGREDIENTS (6)
CROMOLYN SODIUMActive
Quantity: 40 mg in 1 mL
Code: Q2WXR1I0PK
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT