cromolyn sodium inhalation solution (76204-028)

Drug Facts

Product Profile

Brand Name cromolyn sodium inhalation solution

Generic Name cromolyn sodium inhalation solution

Labeler ritedose pharmaceuticals, llc

Dosage Form SOLUTION

Routes

RESPIRATORY (INHALATION)

Active Ingredients

cromolyn sodium 20 mg/2mL

Manufacturer

Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-028

Product ID 76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209453

Listing Expiration 2026-12-31

Marketing Start 2021-12-01

Pharmacologic Class

Classes

decreased histamine release [pe] mast cell stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76204028

Hyphenated Format 76204-028

Supplemental Identifiers

RxCUI

831246

UNII

Q2WXR1I0PK

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cromolyn sodium inhalation solution (source: ndc)

Generic Name cromolyn sodium inhalation solution (source: ndc)

Application Number ANDA209453 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

20 mg/2mL

source: ndc

Packaging

2 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE

source: ndc

Packages (1)

76204-028-60 2 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE

Ingredients (1)

cromolyn sodium (20 mg/2mL)

Linked Drug Pages (1)

Cromolyn Sodium Inhalation Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "459fa0f5-35dd-d6e5-e063-6394a90a6f14", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831246"], "spl_set_id": ["0209cd6c-5c43-0b93-e063-6294a90ac964"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 CARTON (76204-028-60)  / 30 AMPULE in 1 POUCH (76204-028-12)  / 2 mL in 1 AMPULE", "package_ndc": "76204-028-60", "marketing_start_date": "20211201"}], "brand_name": "Cromolyn Sodium Inhalation Solution", "product_id": "76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "76204-028", "generic_name": "Cromolyn Sodium Inhalation Solution", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cromolyn Sodium Inhalation Solution", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "20 mg/2mL"}], "application_number": "ANDA209453", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}