FDA.reportPublic FDA data

BUDESONIDE

Product NDC
59651-585
11-digit product format
596510585
Labeler code
59651
Product ID
59651-585_c70c734f-2431-4414-bb94-4adda4985e5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUDESONIDE
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA216667
Marketing category
ANDA
Marketing start
2023-11-29
Substance
BUDESONIDE
Active strength
.5 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUDESONIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.5 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui351109

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-585-05BUDESONIDE5 in 1 POUCHSUSPENSION51
59651-585-05BUDESONIDE2 mL in 1 AMPULESUSPENSION21
59651-585-30BUDESONIDE6 in 1 CARTONSUSPENSION61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-585BUDESONIDE SUSPENSION [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20231205_c70c734f-2431-4414-bb94-4adda4985e5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNc70c734f-2431-4414-bb94-4adda4985e5d1
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDc70c734f-2431-4414-bb94-4adda4985e5d1
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYc70c734f-2431-4414-bb94-4adda4985e5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-585-05596510585055 in 1 POUCHHistorical
59651-585-30596510585306 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE6 pouch2023-11-29NoNoCurrent