Cromolyn Sodium

Product NDC
17478-291
11-digit product format
174780291
Labeler code
17478
Product ID
17478-291_2c91e02d-0a38-4225-b30d-249fd182568f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA074706
Marketing category
ANDA
Marketing start
1998-04-29
Marketing end
0000-00-00
Substance
CROMOLYN SODIUM
Active strength
40 mg/mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-291-112024-01-30C16284748780-11030e365-2b83-111a-e063-dadaa90a10e2CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4% Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-291-11Cromolyn Sodium1 in 1 CARTONSOLUTION/ DROPS15
17478-291-11Cromolyn Sodium10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-291-11ML - Milliliter17478-2914402d7f0-5460-4224-a508-e4d16d39f46612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cromolyn SodiumACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SOLUTION/ DROPS [AKORN, INC.]2
CromolynACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SOLUTION/ DROPS [AKORN, INC.]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7CROMOLYN SODIUM SOLUTION/ DROPS [AKORN, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCROMOLYN SODIUM SOLUTION/ DROPS [AKORN, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCROMOLYN SODIUM SOLUTION/ DROPS [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-291CROMOLYN SODIUM SOLUTION/ DROPS [AKORN]5Legacy NDC, 2 package rows20220126_e604ed4d-d8a7-4f65-a386-b4bd6137d987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831109cromolyn sodium 4 % Ophthalmic SolutionPSNe604ed4d-d8a7-4f65-a386-b4bd6137d9875
831109cromolyn sodium 40 MG/ML Ophthalmic SolutionSCDe604ed4d-d8a7-4f65-a386-b4bd6137d9875
831109cromolyn sodium 4 % Ophthalmic SolutionSYe604ed4d-d8a7-4f65-a386-b4bd6137d9875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-291-11174780291111 BOTTLE, DROPPER in 1 CARTON (17478-291-11) > 10 mL in 1 BOTTLE, DROPPER1998-04-290000-00-00NoNoCurrent