FDA.reportPublic FDA data

Budesonide

Product NDC
65162-778
11-digit product format
651620778
Labeler code
65162
Product ID
65162-778_ef5a72fa-15a8-427d-83c5-74190a22ecd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-778-10Budesonide100 in 1 BOTTLECAPSULE, DELAYED RELEASE10018
65162-778-18Budesonide180 in 1 BOTTLECAPSULE, DELAYED RELEASE18018
65162-778-30Budesonide300 in 1 BOTTLECAPSULE, DELAYED RELEASE30018
65162-778-49Budesonide21 in 1 BOTTLECAPSULE, DELAYED RELEASE2118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-778-10EA - Each65162-77811e8e0cb-27cf-4996-a3f3-dfcb9757e81512018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-778BUDESONIDE CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 4 package rows20241006_b15102d5-7884-44ed-8340-046d7b516fa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSNb15102d5-7884-44ed-8340-046d7b516fa818
1244214budesonide 3 MG Delayed Release Oral CapsuleSCDb15102d5-7884-44ed-8340-046d7b516fa818
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
65162-778-1065162077810100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10) 2017-09-150000-00-00NoNoCurrent
65162-778-1865162077818180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-18) 2017-09-150000-00-00NoNoCurrent
65162-778-3065162077830300 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-30) 2017-09-150000-00-00NoNoCurrent
65162-778-496516207784921 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-49) 2017-09-150000-00-00NoNoCurrent