FDA.reportPublic FDA data

budesonide

Product NDC
72162-2473
11-digit product format
721622473
Labeler code
72162
Product ID
72162-2473_53dbaeb6-8bff-46dc-afb8-1c6581bb24eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021324
Marketing category
NDA
Marketing start
2018-06-29
Substance
BUDESONIDE
Active strength
3 mg/1
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
BUDESONIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui1244214

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
72162-2473-1budesonide1 in 1 CARTONCAPSULE13
72162-2473-1budesonide100 in 1 BOTTLECAPSULE1003
72162-2473-2budesonide1 in 1 CARTONCAPSULE13
72162-2473-2budesonide100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2473-1EA - Each72162-24736e56c8c4-580a-4d62-82d9-1aa06cd554a312025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2473BUDESONIDE CAPSULE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20250430_33def4dc-b469-f987-e063-6294a90ace0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSN33def4dc-b469-f987-e063-6294a90ace0b3
1244214budesonide 3 MG Delayed Release Oral CapsuleSCD33def4dc-b469-f987-e063-6294a90ace0b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2473-1721622473011 BOTTLE in 1 CARTON (72162-2473-1) / 100 CAPSULE in 1 BOTTLE1 bottle2025-04-24NoNoHistorical
72162-2473-2721622473021 BOTTLE in 1 CARTON (72162-2473-2) / 100 CAPSULE in 1 BOTTLE1 bottle2025-04-24NoNoHistorical