Search by Drug Name or NDC
NDC 76204-0028-60 Cromolyn Sodium Inhalation Solution 20 mg/2mL Details
Cromolyn Sodium Inhalation Solution 20 mg/2mL
Cromolyn Sodium Inhalation Solution is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ritedose Pharmaceuticals, LLC. The primary component is CROMOLYN SODIUM.
MedlinePlus Drug Summary
Cromolyn oral inhalation is used to prevent the wheezing, shortness of breath, difficulty breathing, coughing, and chest tightness caused by asthma. It also is used to prevent breathing difficulties (bronchospasm) caused by exercise, cold and dry air, or by inhaling substances such as pet dander, pollen, dust mites, or chemicals, such as perfume. It works by preventing the release of substances that cause inflammation (swelling) in the air passages of the lungs.
Related Packages: 76204-0028-60Last Updated: 05/26/2024
MedLinePlus Full Drug Details: Cromolyn Oral Inhalation
Product Information
| NDC | 76204-0028 |
|---|---|
| Product ID | 76204-028_027df98e-8a9d-0254-e063-6294a90a350f |
| Associated GPIs | |
| GCN Sequence Number | 011688 |
| GCN Sequence Number Description | cromolyn sodium AMPUL-NEB 20 MG/2 ML INHALATION |
| HIC3 | Z21 |
| HIC3 Description | MAST CELL STABILIZERS, ORALLY INHALED |
| GCN | 46780 |
| HICL Sequence Number | 004526 |
| HICL Sequence Number Description | CROMOLYN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Cromolyn Sodium Inhalation Solution |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cromolyn Sodium Inhalation Solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/2mL |
| Substance Name | CROMOLYN SODIUM |
| Labeler Name | Ritedose Pharmaceuticals, LLC |
| Pharmaceutical Class | Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209453 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76204-0028-60 (76204002860)
| NDC Package Code | 76204-028-60 |
|---|---|
| Billing NDC | 76204002860 |
| Package | 2 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE |
| Marketing Start Date | 2021-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |