FDA.reportPublic FDA data

Gastrocrom

Product NDC
0037-0678
11-digit product format
000370678
Labeler code
0037
Product ID
0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cromolyn sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020479
Marketing category
NDA
Marketing start
2015-05-01
Substance
CROMOLYN SODIUM
Active strength
20 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
Gastrocrom
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROMOLYN SODIUM20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2WXR1I0PK
Rxcui831261, 831269

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
0037-0678-08Gastrocrom5 mL in 1 AMPULELIQUID56
0037-0678-08Gastrocrom8 in 1 POUCHLIQUID86
0037-0678-96Gastrocrom12 in 1 CARTONLIQUID126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-0678-08ML - Milliliter0037-0678421ca1fa-7bf1-4654-9fd5-2ce54861c27512015-11-12
0037-0678-96ML - Milliliter0037-067864f2d9dd-1f68-4f82-a5b9-89f8be11fbcb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKGASTROCROM (CROMOLYN SODIUM) LIQUID [MEDA PHARMACEUTICALS]1
CROMOLYNACTIVE MOIETYY0TK0FS77WGASTROCROM (CROMOLYN SODIUM) LIQUID [MEDA PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RGASTROCROM (CROMOLYN SODIUM) LIQUID [MEDA PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-0678GASTROCROM (CROMOLYN SODIUM) LIQUID [MEDA PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20241101_00623958-a8fe-47d1-a0d2-0aa4e2f7966e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831261cromolyn sodium 100 MG in 5 mL Concentrate for Oral SolutionPSN00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831269Gastrocrom 100 MG in 5 mL Concentrate for Oral SolutionPSN00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831269cromolyn sodium 20 MG/ML Oral Solution [Gastrocrom]SBD00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831261cromolyn sodium 20 MG/ML Oral SolutionSCD00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831261cromolyn sodium 100 MG per 5 ML Concentrate for Oral SolutionSY00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831269Gastrocrom 100 MG per 5 ML Concentrate for Oral SolutionSY00623958-a8fe-47d1-a0d2-0aa4e2f7966e6
831269Gastrocrom 20 MG/ML Oral SolutionSY00623958-a8fe-47d1-a0d2-0aa4e2f7966e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-0678-08000370678085 mL in 1 AMPULE5 mlHistorical
0037-0678-960003706789612 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE12 pouch2015-05-010000-00-00NoNoCurrent