FDA.reportPublic FDA data

CROMOLYN SODIUM

Product NDC
42571-132
11-digit product format
425710132
Labeler code
42571
Product ID
42571-132_22ffea9c-cd39-22dd-e063-6394a90aae4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn sodium
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA202745
Marketing category
ANDA
Marketing start
2013-05-04
Substance
CROMOLYN SODIUM
Active strength
100 mg/5mL
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 SODIUM100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831261

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
42571-132-21CROMOLYN SODIUM5 mL in 1 AMPULESOLUTION, CONCENTRATE512
42571-132-52CROMOLYN SODIUM1 in 1 CARTONSOLUTION, CONCENTRATE112
42571-132-52CROMOLYN SODIUM96 in 1 CARTONSOLUTION, CONCENTRATE9612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-132-21ML - Milliliter42571-1329e291cc0-69cd-4255-b373-4871dcc5dd2712017-04-05
42571-132-51ML - Milliliter42571-132b7d87cd1-ce08-4ec5-9524-4dbcb4f7b17312017-05-03
42571-132-52ML - Milliliter42571-1321e9361f6-92ad-4c93-a263-02b0bf4bafca12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SOLUTION, CONCENTRATE [MICRO LABS LIMITED]4
CROMOLYNACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SOLUTION, CONCENTRATE [MICRO LABS LIMITED]4
WATERINACTIVE INGREDIENT059QF0KO0RCROMOLYN SODIUM SOLUTION, CONCENTRATE [MICRO LABS LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-132CROMOLYN SODIUM SOLUTION, CONCENTRATE [MICRO LABS LIMITED]12Current NDC, Legacy NDC, 3 package rows20240927_93f80edb-3b38-423e-8cd6-5b5cb4393ec2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN93f80edb-3b38-423e-8cd6-5b5cb4393ec212
831261cromolyn sodium 20 MG/ML Oral SolutionSCD93f80edb-3b38-423e-8cd6-5b5cb4393ec212
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY93f80edb-3b38-423e-8cd6-5b5cb4393ec212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-132-21425710132215 mL in 1 AMPULE5 mlHistorical
42571-132-524257101325296 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21) 96 carton2013-05-040000-00-00NoNoCurrent