Cromolyn Sodium

Product NDC
71205-230
11-digit product format
712050230
Labeler code
71205
Product ID
71205-230_1c80e622-005d-44f1-a5a9-2e0acd59e485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA075282
Marketing category
ANDA
Marketing start
1999-06-29
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
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 SODIUM40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831109

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
71205-230-10Cromolyn Sodium10 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-230-10ML - Milliliter71205-23032d3920c-e027-4fd6-908d-ed86657584b012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-230CROMOLYN SODIUM SOLUTION/ DROPS [PROFICIENT RX LP]2Current NDC, Legacy NDC, 1 package rows20191012_34ef00e8-0c01-4225-9a40-822ab245752a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831109cromolyn sodium 4 % Ophthalmic SolutionPSN34ef00e8-0c01-4225-9a40-822ab245752a2
831109cromolyn sodium 40 MG/ML Ophthalmic SolutionSCD34ef00e8-0c01-4225-9a40-822ab245752a2
831109cromolyn sodium 4 % Ophthalmic SolutionSY34ef00e8-0c01-4225-9a40-822ab245752a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-230-107120502301010 mL in 1 BOTTLE, PLASTIC (71205-230-10) 10 ml2019-03-010000-00-00NoNoCurrent