FDA.reportPublic FDA data

Cromolyn Sodium

Product NDC
42571-350
11-digit product format
425710350
Labeler code
42571
Product ID
42571-350_22feddbf-0d9b-8ce7-e063-6394a90a8887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
INHALANT
Route
INTRABRONCHIAL
Labeler
Micro Labs Limited
Application
ANDA213658
Marketing category
ANDA
Marketing start
2022-06-01
Substance
CROMOLYN SODIUM
Active strength
20 mg/2mL
Pharmacologic classes
Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cromolyn Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROMOLYN SODIUM20 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831246

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d745b171-bd61-e8c6-cc94-d4add278788bProduct name320230113
a7fea5a7-679e-334b-faff-75e43fb3beb5Product name220171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-350-08Cromolyn Sodium2 mL in 1 AMPULEINHALANT22
42571-350-09Cromolyn Sodium5 in 1 CARTONINHALANT52
42571-350-09Cromolyn Sodium12 in 1 CARTONINHALANT122
42571-350-50Cromolyn Sodium12 in 1 CARTONINHALANT122
42571-350-50Cromolyn Sodium10 in 1 CARTONINHALANT102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-350-08ML - Milliliter42571-350d3e0d1d9-c63b-4f84-8ab0-02eec611684112025-05-14
42571-350-09ML - Milliliter42571-350f0a9963c-33f0-4a3f-8f20-7f8686ba97f212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-350CROMOLYN SODIUM (CROMOLYN SODIUM) INHALANT [MICRO LABS LIMITED]2Current NDC, Legacy NDC, 5 package rows20240927_aebec664-ed80-447c-9789-0cf47c8b7429.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSNaebec664-ed80-447c-9789-0cf47c8b74292
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCDaebec664-ed80-447c-9789-0cf47c8b74292
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSYaebec664-ed80-447c-9789-0cf47c8b74292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-350-08425710350082 mL in 1 AMPULE2 mlHistorical
42571-350-09425710350095 CARTON in 1 CARTON (42571-350-09) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08) 5 carton2022-06-010000-00-00NoNoCurrent
42571-350-504257103505010 CARTON in 1 CARTON (42571-350-50) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08) 10 carton2022-06-010000-00-00NoNoCurrent