FDA.reportPublic FDA data

Cromolyn Sodium

Product NDC
57782-397
11-digit product format
577820397
Labeler code
57782
Product ID
57782-397_d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f
Type
HUMAN OTC DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bausch & Lomb Incorporated
Application
ANDA075702
Marketing category
ANDA
Marketing start
2001-07-03
Substance
CROMOLYN SODIUM
Active strength
5.2 mg/1
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 SODIUM5.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui1797851

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
57782-397-262023-02-01C16284748780-1f386c64a-0212-0266-e053-dadaa90a7c1aCromolyn Sodium Nasal Solution, USP NASAL SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57782-397-26Cromolyn Sodium200 in 1 BOTTLESPRAY, METERED2008
57782-397-26Cromolyn Sodium1 in 1 CARTONSPRAY, METERED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57782-397-26ML - Milliliter57782-397335c4c72-2ce5-4479-a101-dc5e3016d3fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]3
CROMOLYNACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]3
WATERINACTIVE INGREDIENT059QF0KO0RCROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57782-397CROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 2 package rows20230201_379f4b59-6866-4b5c-9b1b-d8a35b741461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797851cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal SprayPSN379f4b59-6866-4b5c-9b1b-d8a35b7414618
1797851cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal SpraySCD379f4b59-6866-4b5c-9b1b-d8a35b7414618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57782-397-26577820397261 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE1 bottle2001-07-030000-00-00NoNoCurrent