FDA.reportPublic FDA data

ENTOCORT

Product NDC
65483-702
11-digit product format
654830702
Labeler code
65483
Product ID
65483-702_c99a57a5-655a-4ded-9397-eb7881a3e670
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
CAPSULE
Route
ORAL
Labeler
Prometheus Laboratories Inc
Application
NDA021324
Marketing category
NDA
Marketing start
2001-10-29
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
3 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
65483-702-102025-08-15C16284748780-197449f38-b89d-f6ea-e053-dbdaa90aa703fe6530ef-1b23-451f-1290-0e3ef02ec1b5
65483-702-102019-11-13C16284748780-197449f38-b89d-f6ea-e053-dbdaa90aa703fe6530ef-1b23-451f-1290-0e3ef02ec1b5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65483-702-10EA - Each65483-70261e51af3-1570-42f3-b0f8-f6f897a81ed212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
GELATININACTIVE INGREDIENT2G86QN327LENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
TALCINACTIVE INGREDIENT7SEV7J4R1UENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTOCORT EC (BUDESONIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65483-702ENTOCORT EC (BUDESONIDE) CAPSULE [PROMETHEUS LABORATORIES INC]6Legacy NDC20120125_fe6530ef-1b23-451f-1290-0e3ef02ec1b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSN98a4eca1-904c-4355-957a-b5a141573cc22
1244215Entocort EC 3 MG Delayed Release Oral CapsulePSN98a4eca1-904c-4355-957a-b5a141573cc22
1244215budesonide 3 MG Delayed Release Oral Capsule [Entocort]SBD98a4eca1-904c-4355-957a-b5a141573cc22
1244214budesonide 3 MG Delayed Release Oral CapsuleSCD98a4eca1-904c-4355-957a-b5a141573cc22
1244215Entocort EC 3 MG Delayed Release Oral CapsuleSY98a4eca1-904c-4355-957a-b5a141573cc22