FDA.reportPublic FDA data

Budesonide

Product NDC
47335-631
11-digit product format
473350631
Labeler code
47335
Product ID
47335-631_c5265800-f7ea-4258-8555-5465104858a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211922
Marketing category
ANDA
Marketing start
2021-05-01
Substance
BUDESONIDE
Active strength
.25 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.25 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
47335-631-48Budesonide5 in 1 POUCHSUSPENSION54
47335-631-48Budesonide2 mL in 1 AMPULESUSPENSION24
47335-631-49Budesonide6 in 1 CARTONSUSPENSION64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-631-49ML - Milliliter47335-631ef1fe037-2cc6-4075-a103-3622249aa55512021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-631BUDESONIDE SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 3 package rows20211222_a39fbcfc-3ffd-44bd-b882-01f8e1844213.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNd406759d-4c02-4fc0-b513-56b303afca986
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDd406759d-4c02-4fc0-b513-56b303afca986
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYd406759d-4c02-4fc0-b513-56b303afca986
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNa39fbcfc-3ffd-44bd-b882-01f8e18442134
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNa39fbcfc-3ffd-44bd-b882-01f8e18442134
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSNa39fbcfc-3ffd-44bd-b882-01f8e18442134
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDa39fbcfc-3ffd-44bd-b882-01f8e18442134
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDa39fbcfc-3ffd-44bd-b882-01f8e18442134
252559budesonide 0.5 MG/ML Inhalation SuspensionSCDa39fbcfc-3ffd-44bd-b882-01f8e18442134
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYa39fbcfc-3ffd-44bd-b882-01f8e18442134
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYa39fbcfc-3ffd-44bd-b882-01f8e18442134
252559budesonide 1 MG per 2 ML Inhalation SuspensionSYa39fbcfc-3ffd-44bd-b882-01f8e18442134
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNc7df2a10-4166-423e-bb60-5f3a8234f26c3
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDc7df2a10-4166-423e-bb60-5f3a8234f26c3
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYc7df2a10-4166-423e-bb60-5f3a8234f26c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-631-48473350631485 in 1 POUCHHistorical
47335-631-49473350631496 POUCH in 1 CARTON (47335-631-49) / 5 AMPULE in 1 POUCH (47335-631-48) / 2 mL in 1 AMPULE6 pouch2021-05-010000-00-00NoNoCurrent