FDA.reportPublic FDA data

budesonide

Product NDC
70771-1075
11-digit product format
707711075
Labeler code
70771
Product ID
70771-1075_bfde9c2e-2ff5-4258-91bc-78a48b228d14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
70771-1075-0budesonide1000 in 1 BOTTLECAPSULE, COATED PELLETS10008
70771-1075-1budesonide100 in 1 BOTTLECAPSULE, COATED PELLETS1008
70771-1075-3budesonide30 in 1 BOTTLECAPSULE, COATED PELLETS308
70771-1075-4budesonide10 in 1 CARTONCAPSULE, COATED PELLETS108
70771-1075-4budesonide10 in 1 BLISTER PACKCAPSULE, COATED PELLETS108
70771-1075-5budesonide500 in 1 BOTTLECAPSULE, COATED PELLETS5008
70771-1075-9budesonide90 in 1 BOTTLECAPSULE, COATED PELLETS908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1075BUDESONIDE CAPSULE, COATED PELLETS [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20250214_d645a346-c99b-4de7-9bca-69e73266d6b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244214budesonide 3 MG Delayed Release Oral CapsulePSNd645a346-c99b-4de7-9bca-69e73266d6b48
1244214budesonide 3 MG Delayed Release Oral CapsuleSCDd645a346-c99b-4de7-9bca-69e73266d6b48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1075-0707711075001000 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-0) 2017-06-080000-00-00NoNoCurrent
70771-1075-170771107501100 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-1) 2017-06-080000-00-00NoNoCurrent
70771-1075-37077110750330 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-3) 2017-06-080000-00-00NoNoCurrent
70771-1075-47077110750410 BLISTER PACK in 1 CARTON (70771-1075-4) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK10 blister pack2017-06-080000-00-00NoNoCurrent
70771-1075-570771107505500 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-5) 2017-06-080000-00-00NoNoCurrent
70771-1075-97077110750990 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-9) 2017-06-080000-00-00NoNoCurrent