FDA.reportPublic FDA data

Budesonide

Product NDC
63629-8294
11-digit product format
636298294
Labeler code
63629
Product ID
63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206200
Marketing category
ANDA
Marketing start
2017-09-15
Substance
BUDESONIDE
Active strength
3 mg/1
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8294-12024-05-10C16284748780-11030e365-0011-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUDESONIDE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for BUDESONIDE DELAYED-RELEASE CAPSULES. BUDESONIDE delayed-release capsules, for oral use Initial U.S. Approval: 1997
63629-8294-12024-01-30C16284748780-11030e365-0011-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUDESONIDE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for BUDESONIDE DELAYED-RELEASE CAPSULES. BUDESONIDE delayed-release capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8294-1Budesonide30 in 1 BOTTLECAPSULE, DELAYED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8294BUDESONIDE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 1 package rows20241109_4943ef5b-f48b-49d6-b419-467f71ef64e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSN4943ef5b-f48b-49d6-b419-467f71ef64e04
1244214budesonide 3 MG Delayed Release Oral CapsuleSCD4943ef5b-f48b-49d6-b419-467f71ef64e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8294-16362982940130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1) 2020-02-060000-00-00NoNoCurrent