cromolyn sodium

Generic: cromolyn sodium

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium
Generic Name cromolyn sodium
Labeler micro labs limited
Dosage Form INHALANT
Routes
INTRABRONCHIAL
Active Ingredients

cromolyn sodium 20 mg/2mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-350
Product ID 42571-350_22feddbf-0d9b-8ce7-e063-6394a90a8887
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213658
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571350
Hyphenated Format 42571-350

Supplemental Identifiers

RxCUI
831246
UPC
0342571350086
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 ANDA213658 (source: ndc)
Routes
INTRABRONCHIAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/2mL
source: ndc
Packaging
  • 5 CARTON in 1 CARTON (42571-350-09) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)
  • 10 CARTON in 1 CARTON (42571-350-50) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)
source: ndc

Packages (2)

42571-350-09 5 CARTON in 1 CARTON (42571-350-09) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08) 42571-350-50 10 CARTON in 1 CARTON (42571-350-50) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)

Ingredients (1)

cromolyn sodium (20 mg/2mL)

Linked Drug Pages (1)

Cromolyn Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRABRONCHIAL"], "spl_id": "22feddbf-0d9b-8ce7-e063-6394a90a8887", "openfda": {"upc": ["0342571350086"], "unii": ["Q2WXR1I0PK"], "rxcui": ["831246"], "spl_set_id": ["aebec664-ed80-447c-9789-0cf47c8b7429"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTON in 1 CARTON (42571-350-09)  / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)", "package_ndc": "42571-350-09", "marketing_start_date": "20220601"}, {"sample": false, "description": "10 CARTON in 1 CARTON (42571-350-50)  / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08)", "package_ndc": "42571-350-50", "marketing_start_date": "20220601"}], "brand_name": "Cromolyn Sodium", "product_id": "42571-350_22feddbf-0d9b-8ce7-e063-6394a90a8887", "dosage_form": "INHALANT", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "42571-350", "generic_name": "Cromolyn Sodium", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cromolyn Sodium", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "20 mg/2mL"}], "application_number": "ANDA213658", "marketing_category": "ANDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}