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Cromolyn Sodium Inhalation Solution

Cromolyn Sodium Inhalation Solution, 20 mg/2 mL

Approved
Approval ID

0209cd6c-5c43-0b93-e063-6294a90ac964

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 9, 2023

Manufacturers
FDA

Ritedose Pharmaceuticals, LLC

DUNS: 968062294

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cromolyn Sodium Inhalation Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76204-028
Application NumberANDA209453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium Inhalation Solution
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 9, 2023
FDA Product Classification

INGREDIENTS (2)

CROMOLYN SODIUMActive
Quantity: 20 mg in 2 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cromolyn Sodium Inhalation Solution - FDA Drug Approval Details