FDA.reportPublic FDA data

Budesonide

Product NDC
0093-6817
11-digit product format
000936817
Labeler code
0093
Product ID
0093-6817_e505244f-d53f-4dc0-acd7-45dc98034b97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA204548
Marketing category
ANDA
Marketing start
2016-03-11
Substance
BUDESONIDE
Active strength
1 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
BUDESONIDE1 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui252559

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
0093-6817-19Budesonide2 mL in 1 AMPULESUSPENSION25
0093-6817-45Budesonide5 in 1 POUCHSUSPENSION55
0093-6817-73Budesonide6 in 1 CARTONSUSPENSION65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-6817-19ML - Milliliter0093-68176bec8b50-b82c-479c-b7a8-5203023e2f0412018-03-08
0093-6817-45ML - Milliliter0093-6817e4406ee8-9efd-477f-9242-612d8bddd62212016-04-04
0093-6817-73ML - Milliliter0093-68177a4ae856-cde4-4680-bc2b-cb6cdea82ebc12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-6817BUDESONIDE SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]5Current NDC, Legacy NDC, 3 package rows20200416_d90ffda1-12c7-4726-90e9-64bb103e84b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSNd90ffda1-12c7-4726-90e9-64bb103e84b55
252559budesonide 0.5 MG/ML Inhalation SuspensionSCDd90ffda1-12c7-4726-90e9-64bb103e84b55
252559budesonide 1 MG per 2 ML Inhalation SuspensionSYd90ffda1-12c7-4726-90e9-64bb103e84b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-6817-19000936817192 mL in 1 AMPULE2 mlHistorical
0093-6817-45000936817455 in 1 POUCHHistorical
0093-6817-73000936817736 POUCH in 1 CARTON (0093-6817-73) / 5 AMPULE in 1 POUCH (0093-6817-45) / 2 mL in 1 AMPULE (0093-6817-19) 6 pouch2016-03-110000-00-00NoNoCurrent