cromolyn sodium

Generic: cromolyn sodium

Labeler: bausch & lomb incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium
Generic Name cromolyn sodium
Labeler bausch & lomb incorporated
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

cromolyn sodium 5.2 mg/1

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 57782-397
Product ID 57782-397_d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075702
Listing Expiration 2026-12-31
Marketing Start 2001-07-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57782397
Hyphenated Format 57782-397

Supplemental Identifiers

RxCUI
1797851
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 ANDA075702 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 5.2 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (1)

57782-397-26 1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE

Ingredients (1)

cromolyn sodium (5.2 mg/1)

Linked Drug Pages (1)

Cromolyn Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["1797851"], "spl_set_id": ["379f4b59-6866-4b5c-9b1b-d8a35b741461"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57782-397-26)  / 200 SPRAY, METERED in 1 BOTTLE", "package_ndc": "57782-397-26", "marketing_start_date": "20010703"}], "brand_name": "Cromolyn Sodium", "product_id": "57782-397_d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f", "dosage_form": "SPRAY, METERED", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "57782-397", "generic_name": "Cromolyn Sodium", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cromolyn Sodium", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "5.2 mg/1"}], "application_number": "ANDA075702", "marketing_category": "ANDA", "marketing_start_date": "20010703", "listing_expiration_date": "20261231"}