Cromolyn Sodium

Product NDC
50090-1202
11-digit product format
500901202
Labeler code
50090
Product ID
50090-1202_b616081b-35e0-4507-aaa1-1f2d7cc80fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA075282
Marketing category
ANDA
Marketing start
1999-06-29
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
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 SODIUM40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831109

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
50090-1202-0Cromolyn Sodium10 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1202-0ML - Milliliter50090-1202a48b5ca5-adbe-49c8-a093-21bc4c8b826812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1202CROMOLYN SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 1 package rows20241108_0d30fb0a-e343-426d-8203-5816bd4cec2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831109cromolyn sodium 4 % Ophthalmic SolutionPSN0d30fb0a-e343-426d-8203-5816bd4cec2f14
831109cromolyn sodium 40 MG/ML Ophthalmic SolutionSCD0d30fb0a-e343-426d-8203-5816bd4cec2f14
831109cromolyn sodium 4 % Ophthalmic SolutionSY0d30fb0a-e343-426d-8203-5816bd4cec2f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1202-05009012020010 mL in 1 BOTTLE, PLASTIC (50090-1202-0) 10 ml2014-11-280000-00-00NoNoCurrent