Cromolyn Sodium

Product NDC
53002-0140
11-digit product format
530020140
Labeler code
53002
Product ID
53002-0140_1e6c1140-abd9-44ea-b043-a00db4789c6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075282
Marketing category
ANDA
Marketing start
1999-06-29
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
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
53002-0140-1Cromolyn Sodium10 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0140CROMOLYN SODIUM SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_f7a6334c-7b98-4730-8ee6-ca37cf87bba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831109cromolyn sodium 4 % Ophthalmic SolutionPSNf7a6334c-7b98-4730-8ee6-ca37cf87bba33
831109cromolyn sodium 40 MG/ML Ophthalmic SolutionSCDf7a6334c-7b98-4730-8ee6-ca37cf87bba33
831109cromolyn sodium 4 % Ophthalmic SolutionSYf7a6334c-7b98-4730-8ee6-ca37cf87bba33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0140-15300201400110 mL in 1 BOTTLE, PLASTIC (53002-0140-1) 10 ml2020-01-010000-00-00NoNoCurrent