FDA.reportPublic FDA data

Budesonide

Product NDC
76282-641
11-digit product format
762820641
Labeler code
76282
Product ID
76282-641_c53a81a4-fad8-4587-ac13-cc4de968485e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
INHALANT
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA205710
Marketing category
ANDA
Marketing start
2019-04-17
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
Brand name suffix
Inhalation Suspension
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui252559, 349094, 351109

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
76282-641-37BudesonideInhalation Suspension2 mL in 1 AMPULEINHALANT24
76282-641-37BudesonideInhalation Suspension5 in 1 POUCHINHALANT54
76282-641-38BudesonideInhalation Suspension6 in 1 CARTONINHALANT64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-641BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [EXELAN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20201212_d9656442-4587-4867-9a8c-5f5b0402936e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSNd9656442-4587-4867-9a8c-5f5b0402936e4
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 0.5 MG/ML Inhalation SuspensionSCDd9656442-4587-4867-9a8c-5f5b0402936e4
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4
252559budesonide 1 MG per 2 ML Inhalation SuspensionSYd9656442-4587-4867-9a8c-5f5b0402936e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-641-37762820641372 mL in 1 AMPULE2 mlHistorical
76282-641-38762820641386 POUCH in 1 CARTON (76282-641-38) / 5 AMPULE in 1 POUCH (76282-641-37) / 2 mL in 1 AMPULE6 pouch2019-04-170000-00-00NoNoCurrent