FDA.reportPublic FDA data

Tarpeyo

Product NDC
81749-004
11-digit product format
817490004
Labeler code
81749
Product ID
81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Calliditas Therapeutics AB
Application
NDA215935
Marketing category
NDA
Marketing start
2021-12-15
Substance
BUDESONIDE
Active strength
4 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
Tarpeyo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui2587883, 2587889

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
81749-004-01Tarpeyo120 in 1 BOTTLECAPSULE, DELAYED RELEASE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81749-004-01EA - Each81749-004db4d8749-212b-41b0-a3bf-ecdbbf88e6e712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81749-004TARPEYO (BUDESONIDE) CAPSULE, DELAYED RELEASE [CALLIDITAS THERAPEUTICS AB]4Current NDC, Legacy NDC, 1 package rows20240619_938cada4-d6bf-4252-836f-dd40f9eadb4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587883budesonide 4 MG Delayed Release Oral CapsulePSN938cada4-d6bf-4252-836f-dd40f9eadb4d5
2587889TARPEYO 4 MG Delayed Release Oral CapsulePSN938cada4-d6bf-4252-836f-dd40f9eadb4d5
2587889budesonide 4 MG Delayed Release Oral Capsule [Tarpeyo]SBD938cada4-d6bf-4252-836f-dd40f9eadb4d5
2587883budesonide 4 MG Delayed Release Oral CapsuleSCD938cada4-d6bf-4252-836f-dd40f9eadb4d5
2587889Tarpeyo 4 MG Delayed Release Oral CapsuleSY938cada4-d6bf-4252-836f-dd40f9eadb4d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81749-004-0181749000401120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01) 2021-12-150000-00-00NoNoCurrent