FDA.reportPublic FDA data

CROMOLYN SODIUM

Product NDC
16571-600
11-digit product format
165710600
Labeler code
16571
Product ID
16571-600_ca2c72ae-db00-4694-9fd0-d4b6b45f8108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CROMOLYN SODIUM
Dosage form
SOLUTION, CONCENTRATE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202583
Marketing category
ANDA
Marketing start
2011-12-05
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
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 SODIUM100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d745b171-bd61-e8c6-cc94-d4add278788bProduct name320230113
a7fea5a7-679e-334b-faff-75e43fb3beb5Product name220171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-600-96CROMOLYN SODIUM8 in 1 POUCHSOLUTION, CONCENTRATE87
16571-600-96CROMOLYN SODIUM12 in 1 CARTONSOLUTION, CONCENTRATE127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-600-96ML - Milliliter16571-6008bc7ddb1-5a25-418b-b440-616cf3abd7bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SOLUTION, CONCENTRATE [PACK PHARMACEUTICALS, LLC]2
CROMOLYNACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SOLUTION, CONCENTRATE [PACK PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-600CROMOLYN SODIUM SOLUTION, CONCENTRATE [RISING PHARMA HOLDINGS, INC.]7Current NDC, Legacy NDC, 2 package rows20220115_61c9cb85-129e-4490-b5f7-357307fcecbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN61c9cb85-129e-4490-b5f7-357307fcecbf7
831261cromolyn sodium 20 MG/ML Oral SolutionSCD61c9cb85-129e-4490-b5f7-357307fcecbf7
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY61c9cb85-129e-4490-b5f7-357307fcecbf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-600-961657106009612 POUCH in 1 CARTON (16571-600-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE12 pouch2011-12-050000-00-00NoNoCurrent