FDA.reportPublic FDA data

Cromolyn Sodium

Product NDC
0172-6406
11-digit product format
001726406
Labeler code
0172
Product ID
0172-6406_38833b9a-b1dd-4e33-b8a3-806fa99eb4a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075271
Marketing category
ANDA
Marketing start
2000-01-18
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
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
a7fea5a7-679e-334b-faff-75e43fb3beb5Product name220171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0172-6406-05Cromolyn Sodium2 mL in 1 VIAL, SINGLE-DOSESOLUTION29
0172-6406-05Cromolyn Sodium5 in 1 POUCHSOLUTION59
0172-6406-49Cromolyn Sodium12 in 1 CARTONSOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-6406-05ML - Milliliter0172-64066bc54976-9530-45b5-bc30-cf12377e21b012015-05-05
0172-6406-49ML - Milliliter0172-64068ea1bd01-526a-4f58-a460-0ed81f61952d12012-07-24
0172-6406-59ML - Milliliter0172-6406ca7a2596-94b6-4733-872e-5f49965417b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3
CROMOLYNACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-6406CROMOLYN SODIUM SOLUTION [TEVA PHARMACEUTICALS USA, INC.]9Current NDC, Legacy NDC, 3 package rows20240201_8fe37a7a-edd6-4733-bb7e-e01c1906aeba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSN8fe37a7a-edd6-4733-bb7e-e01c1906aeba9
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCD8fe37a7a-edd6-4733-bb7e-e01c1906aeba9
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSY8fe37a7a-edd6-4733-bb7e-e01c1906aeba9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0172-6406-05001726406052 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0172-6406-490017264064912 POUCH in 1 CARTON (0172-6406-49) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0172-6406-05) / 2 mL in 1 VIAL, SINGLE-DOSE12 pouch2000-01-180000-00-00NoNoCurrent