CROMOLYN SODIUM

Product NDC
69784-200
11-digit product format
697840200
Labeler code
69784
Product ID
69784-200_dde8609f-d587-4882-9a15-3fd5565dd2b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CROMOLYN SODIUM
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Woodward Pharma Services 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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-200-96ML - Milliliter69784-200daf2e8ef-1d92-47fc-9703-5bcb066df14e12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-200CROMOLYN SODIUM SOLUTION, CONCENTRATE [WOODWARD PHARMA SERVICES LLC]7Legacy NDC20250114_6be24bee-c252-49d3-8352-399ad8394f2d.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
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN6440340a-990a-487f-9248-92b486dea5df105
831261cromolyn sodium 20 MG/ML Oral SolutionSCD6440340a-990a-487f-9248-92b486dea5df105
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY6440340a-990a-487f-9248-92b486dea5df105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69784-200-966978402009612 POUCH in 1 CARTON (69784-200-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE12 pouch2017-10-160000-00-00NoNoCurrent