Cromolyn Sodium
PRESCRIBING INFORMATION
Approved
Approval ID
476a6d06-36a2-4935-b061-6d54498eeca8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 14, 2023
Manufacturers
FDA
Ailex Pharmaceuticals, LLC
DUNS: 080190901
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 Code70556-102
Application NumberANDA209453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium
Product Specifications
Route of AdministrationINTRABRONCHIAL
Effective DateAugust 14, 2023
FDA Product Classification
INGREDIENTS (2)
CROMOLYN SODIUMActive
Quantity: 20 mg in 2 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT