FDA.reportPublic FDA data

Budesonide

Product NDC
0536-1112
11-digit product format
005361112
Labeler code
0536
Product ID
0536-1112_ce26c1bb-c50d-7731-6877-0b8a5fda98df
Type
HUMAN OTC DRUG
Nonproprietary name
Budesonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rugby Laboratories
Application
ANDA078949
Marketing category
ANDA
Marketing start
2016-07-27
Marketing end
2027-06-30
Substance
BUDESONIDE
Active strength
32 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE32 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui1797929

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0536-1112-40Budesonide1 in 1 CARTONSPRAY, METERED112
0536-1112-40Budesonide60 in 1 BOTTLE, SPRAYSPRAY, METERED6012
0536-1112-48Budesonide120 in 1 BOTTLE, SPRAYSPRAY, METERED12012
0536-1112-48Budesonide1 in 1 CARTONSPRAY, METERED112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1112BUDESONIDE SPRAY, METERED [RUGBY LABORATORIES]8Current NDC, Legacy NDC, 4 package rows20241004_04eb9e98-1323-353f-3fd7-2d317dfac526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797929budesonide 32 MCG/ACTUAT Metered Dose Nasal SprayPSN04eb9e98-1323-353f-3fd7-2d317dfac52612
1797929budesonide 0.032 MG/ACTUAT Metered Dose Nasal SpraySCD04eb9e98-1323-353f-3fd7-2d317dfac52612
1797929budesonide 32 MCG/ACTUAT Metered Dose Nasal SpraySY04eb9e98-1323-353f-3fd7-2d317dfac52612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1112-40005361112401 BOTTLE, SPRAY in 1 CARTON (0536-1112-40) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY2016-07-200000-00-00NoNoCurrent
0536-1112-48005361112481 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2016-07-272027-06-30NoNoCurrent