cromolyn sodium

Generic: cromolyn sodium

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium
Generic Name cromolyn sodium
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

cromolyn sodium 40 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8490
Product ID 68788-8490_aaddc929-8d3d-47fe-bb00-f2963df993c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075282
Listing Expiration 2026-12-31
Marketing Start 2023-07-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888490
Hyphenated Format 68788-8490

Supplemental Identifiers

RxCUI
831109
UNII
Q2WXR1I0PK

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 (source: ndc)
Generic Name cromolyn sodium (source: ndc)
Application Number ANDA075282 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, PLASTIC (68788-8490-1)
source: ndc

Packages (1)

68788-8490-1 10 mL in 1 BOTTLE, PLASTIC (68788-8490-1)

Ingredients (1)

cromolyn sodium (40 mg/mL)

Linked Drug Pages (1)

Cromolyn Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "aaddc929-8d3d-47fe-bb00-f2963df993c3", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831109"], "spl_set_id": ["18892411-465f-4d8d-9550-7dafa6c6a0a3"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (68788-8490-1)", "package_ndc": "68788-8490-1", "marketing_start_date": "20230721"}], "brand_name": "Cromolyn Sodium", "product_id": "68788-8490_aaddc929-8d3d-47fe-bb00-f2963df993c3", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "68788-8490", "generic_name": "Cromolyn Sodium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cromolyn Sodium", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "40 mg/mL"}], "application_number": "ANDA075282", "marketing_category": "ANDA", "marketing_start_date": "20230721", "listing_expiration_date": "20261231"}