FDA.reportPublic FDA data

CROMOLYN SODIUM

Product NDC
63629-2485
11-digit product format
636292485
Labeler code
63629
Product ID
63629-2485_15866388-4c3b-4ecc-a60a-0fa4481e55c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CROMOLYN SODIUM
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209264
Marketing category
ANDA
Marketing start
2017-10-16
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
63629-2485-1CROMOLYN SODIUM12 in 1 CARTONSOLUTION, CONCENTRATE12107
63629-2485-1CROMOLYN SODIUM8 in 1 POUCHSOLUTION, CONCENTRATE8107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2485-1ML - Milliliter63629-248581bb80b5-34c4-452a-ae5f-b3a106b029c512021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2485CROMOLYN SODIUM SOLUTION, CONCENTRATE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 2 package rows20240913_8b84de1e-0c12-40c9-8185-00878ec6ada6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN8b84de1e-0c12-40c9-8185-00878ec6ada6107
831261cromolyn sodium 20 MG/ML Oral SolutionSCD8b84de1e-0c12-40c9-8185-00878ec6ada6107
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY8b84de1e-0c12-40c9-8185-00878ec6ada6107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2485-16362924850112 POUCH in 1 CARTON (63629-2485-1) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE12 pouch2017-10-160000-00-00NoNoCurrent