cromolyn sodium

Generic: cromolyn sodium

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cromolyn sodium 40 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-237
Product ID 61314-237_4d6f900a-fa36-445e-80d5-54c8cc5baf34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075282
Listing Expiration 2026-12-31
Marketing Start 1999-06-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314237
Hyphenated Format 61314-237

Supplemental Identifiers

RxCUI
831109
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 (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 (61314-237-10)
source: ndc

Packages (1)

61314-237-10 10 mL in 1 BOTTLE, PLASTIC (61314-237-10)

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": "4d6f900a-fa36-445e-80d5-54c8cc5baf34", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831109"], "spl_set_id": ["b32851c3-cd97-4be4-a09c-1deab1d6966b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (61314-237-10)", "package_ndc": "61314-237-10", "marketing_start_date": "19990629"}], "brand_name": "Cromolyn Sodium", "product_id": "61314-237_4d6f900a-fa36-445e-80d5-54c8cc5baf34", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "61314-237", "generic_name": "Cromolyn Sodium", "labeler_name": "Sandoz 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": "19990629", "listing_expiration_date": "20261231"}