FDA.reportPublic FDA data

budesonide

Product NDC
68382-720
11-digit product format
683820720
Labeler code
68382
Product ID
68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206134
Marketing category
ANDA
Marketing start
2017-06-08
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
68382-720-01budesonide100 in 1 BOTTLECAPSULE, COATED PELLETS10010
68382-720-05budesonide500 in 1 BOTTLECAPSULE, COATED PELLETS50010
68382-720-06budesonide30 in 1 BOTTLECAPSULE, COATED PELLETS3010
68382-720-10budesonide1000 in 1 BOTTLECAPSULE, COATED PELLETS100010
68382-720-16budesonide90 in 1 BOTTLECAPSULE, COATED PELLETS9010
68382-720-30budesonide10 in 1 BLISTER PACKCAPSULE, COATED PELLETS1010
68382-720-77budesonide10 in 1 CARTONCAPSULE, COATED PELLETS1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-720-01EA - Each68382-720cf596e2e-722f-45a4-a47c-7f092dd5896112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-720BUDESONIDE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 7 package rows20250214_29863154-5f98-410e-9bf3-0f08b551edef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSN29863154-5f98-410e-9bf3-0f08b551edef10
1244214budesonide 3 MG Delayed Release Oral CapsuleSCD29863154-5f98-410e-9bf3-0f08b551edef10
1244214budesonide 3 MG Delayed Release Oral CapsulePSN4a8e79df-3946-4e9a-b214-e9fdd824b5654
1244214budesonide 3 MG Delayed Release Oral CapsuleSCD4a8e79df-3946-4e9a-b214-e9fdd824b5654
1244214budesonide 3 MG Delayed Release Oral CapsulePSNe7aca8d1-159e-4aac-b92d-3a69a8edceec2
1244214budesonide 3 MG Delayed Release Oral CapsuleSCDe7aca8d1-159e-4aac-b92d-3a69a8edceec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-720-0168382072001100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01) 2017-06-080000-00-00NoNoCurrent
68382-720-0568382072005500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05) 2017-06-080000-00-00NoNoCurrent
68382-720-066838207200630 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06) 2017-06-080000-00-00NoNoCurrent
68382-720-10683820720101000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10) 2017-06-080000-00-00NoNoCurrent
68382-720-166838207201690 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16) 2017-06-080000-00-00NoNoCurrent
68382-720-306838207203010 in 1 BLISTER PACKHistorical
68382-720-776838207207710 BLISTER PACK in 1 CARTON (68382-720-77) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30) 10 blister pack2017-06-080000-00-00NoNoCurrent