cromolyn sodium oral solution (concentrate)

Generic: cromolyn sodium oral solution (concentrate)

Labeler: ritedose pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium oral solution (concentrate)
Generic Name cromolyn sodium oral solution (concentrate)
Labeler ritedose pharmaceuticals, llc
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

cromolyn sodium 100 mg/5mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-025
Product ID 76204-025_459fa806-53ad-d48e-e063-6394a90af72b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209264
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 76204025
Hyphenated Format 76204-025

Supplemental Identifiers

RxCUI
831261
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 oral solution (concentrate) (source: ndc)
Generic Name cromolyn sodium oral solution (concentrate) (source: ndc)
Application Number ANDA209264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (76204-025-96) / 8 AMPULE in 1 POUCH (76204-025-08) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

76204-025-96 12 POUCH in 1 CARTON (76204-025-96) / 8 AMPULE in 1 POUCH (76204-025-08) / 5 mL in 1 AMPULE

Ingredients (1)

cromolyn sodium (100 mg/5mL)

Linked Drug Pages (1)

Cromolyn Sodium Oral Solution (Concentrate) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "459fa806-53ad-d48e-e063-6394a90af72b", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831261"], "spl_set_id": ["d208df15-c823-6e0d-e053-2a95a90ad1be"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (76204-025-96)  / 8 AMPULE in 1 POUCH (76204-025-08)  / 5 mL in 1 AMPULE", "package_ndc": "76204-025-96", "marketing_start_date": "20211201"}], "brand_name": "Cromolyn Sodium Oral Solution (Concentrate)", "product_id": "76204-025_459fa806-53ad-d48e-e063-6394a90af72b", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "76204-025", "generic_name": "Cromolyn Sodium Oral Solution (Concentrate)", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cromolyn Sodium Oral Solution (Concentrate)", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "100 mg/5mL"}], "application_number": "ANDA209264", "marketing_category": "ANDA", "marketing_start_date": "20211201", "listing_expiration_date": "20261231"}