Cromolyn Sodium

Product NDC
70556-102
11-digit product format
705560102
Labeler code
70556
Product ID
70556-102_b8f6054d-8a9a-49b0-a3b2-da4ae2544d7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Ailex Pharmaceuticals, LLC
Application
ANDA209264
Marketing category
ANDA
Marketing start
2017-10-24
Marketing end
0000-00-00
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70556-102-30Cromolyn Sodium30 in 1 POUCHSOLUTION304
70556-102-30Cromolyn Sodium2 mL in 1 VIAL, SINGLE-DOSESOLUTION24
70556-102-60Cromolyn Sodium2 in 1 CARTONSOLUTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70556-102CROMOLYN SODIUM SOLUTION [AILEX PHARMACEUTICALS, LLC]4Legacy NDC, 3 package rows20231109_476a6d06-36a2-4935-b061-6d54498eeca8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSN476a6d06-36a2-4935-b061-6d54498eeca84
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCD476a6d06-36a2-4935-b061-6d54498eeca84
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSY476a6d06-36a2-4935-b061-6d54498eeca84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70556-102-307055601023030 in 1 POUCHHistorical
70556-102-60705560102602 POUCH in 1 CARTON (70556-102-60) > 30 VIAL, SINGLE-DOSE in 1 POUCH (70556-102-30) > 2 mL in 1 VIAL, SINGLE-DOSE2 pouch2017-10-240000-00-00NoNoCurrent