FDA.reportPublic FDA data

Cromolyn Sodium Inhalation Solution

Product NDC
76204-028
11-digit product format
762040028
Labeler code
76204
Product ID
76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium Inhalation Solution
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA209453
Marketing category
ANDA
Marketing start
2021-12-01
Substance
CROMOLYN SODIUM
Active strength
20 mg/2mL
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 Inhalation Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROMOLYN SODIUM20 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831246

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d745b171-bd61-e8c6-cc94-d4add278788bProduct name320230113
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a7fea5a7-679e-334b-faff-75e43fb3beb5Product name220171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-028-12Cromolyn Sodium Inhalation Solution2 mL in 1 AMPULESOLUTION26
76204-028-12Cromolyn Sodium Inhalation Solution30 in 1 POUCHSOLUTION306
76204-028-60Cromolyn Sodium Inhalation Solution2 in 1 CARTONSOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-028-12ML - Milliliter76204-028ae1bd5b0-873f-49af-9ca6-843f061c97f712024-04-05
76204-028-60ML - Milliliter76204-028920839ef-a122-4631-88e2-e93ab80e5d3a12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-028CROMOLYN SODIUM INHALATION SOLUTION SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20241219_0209cd6c-5c43-0b93-e063-6294a90ac964.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSN0209cd6c-5c43-0b93-e063-6294a90ac9646
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCD0209cd6c-5c43-0b93-e063-6294a90ac9646
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSY0209cd6c-5c43-0b93-e063-6294a90ac9646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76204-028-12762040028122 mL in 1 AMPULE2 mlHistorical
76204-028-60762040028602 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE2 pouch2021-12-01NoNoCurrent