CROMOLYN SODIUM

Product NDC
70556-101
11-digit product format
705560101
Labeler code
70556
Product ID
70556-101_178e3342-2eeb-441a-9ab9-e47d8e3c4dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CROMOLYN SODIUM
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Ailex Pharmaceuticals, LLC
Application
ANDA209264
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70556-101-962022-01-28C16284748780-1d6a99b39-b5de-a426-e053-dadaa90af4c2Cromolyn Sodium Oral Solution, Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70556-101-96CROMOLYN SODIUM8 in 1 POUCHSOLUTION, CONCENTRATE83
70556-101-96CROMOLYN SODIUM12 in 1 CARTONSOLUTION, CONCENTRATE123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70556-101CROMOLYN SODIUM SOLUTION, CONCENTRATE [AILEX PHARMACEUTICALS, LLC]3Legacy NDC, 2 package rows20201228_7143e897-03d2-4ef9-b95a-3d43f971b3bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN7143e897-03d2-4ef9-b95a-3d43f971b3bd3
831261cromolyn sodium 20 MG/ML Oral SolutionSCD7143e897-03d2-4ef9-b95a-3d43f971b3bd3
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY7143e897-03d2-4ef9-b95a-3d43f971b3bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70556-101-967055601019612 POUCH in 1 CARTON (70556-101-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE12 pouch2017-10-160000-00-00NoNoCurrent