FDA.reportPublic FDA data

NDC 70771-1075-01 - budesonide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70771-1075
Requested NDC
70771-1075-01
Package NDCs from labels
70771-1075-3, 70771-1075-9, 70771-1075-1, 70771-1075-5, 70771-1075-0, 70771-1075-4, 70771-1075-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2025-02-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
budesonide - Zydus Lifesciences LimitedZydus Lifesciences Limited2025-02-12HUMAN PRESCRIPTION DRUG LABEL

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 82 of 322 · 6,423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AdvancedETHYL ALCOHOLTopco Associates LLCfaaa3452-ef1e-47db-9978-5105de69d9812026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLTopco Associates LLC686dd9a1-13db-4a2b-ba04-492d14e81b562026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Advanced Hand SanitizerALCOHOLWakefern Food Corp.9859ef63-70a7-4986-ad22-0c1c7333c6cb2026-02-13WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLWakefern Food Corp.c441a053-d241-48b4-a33b-971b890f27402026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWakefern Food Corp.c5dd2b25-9003-4c4b-8a86-ecf186695ce32026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
BCBG GENERATION HAND SANITIZER BERGAMOT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOfaba4dec-67dc-4db0-a48b-e39b3edf2f992026-02-13WarningsExact identifier
unii: 3K9958V90M
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
Smart Care VANILLA HEAVEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.43c129d8-0ad3-4630-acd9-b604cbda36e02026-02-13WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLWinCo Foods, LLC5f5ee353-2387-4b15-af39-5bbe3fda4dc42026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLWinco Foods25204aac-e940-45dc-804b-81fd141449d72026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWalgreen Co.1e879904-055e-4bec-a504-3c783fc9fb242026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Spectrum Hand SanitizerETHYL ALCOHOLMedline Industries, LP70598373-bc89-07b9-e053-2991aa0a9e9a2026-02-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLMedline Industries, LPf84f7050-348d-4f75-ab93-e618ff8de7902026-02-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLMedline Industries, LP42813b3e-dfae-495c-bffb-bf3862857cb12026-02-11WarningsExact identifier
unii: 3K9958V90M
Spectrum 62% Hand SanitizerETHYL ALCOHOLMedline Industries, LP6971b7de-039d-292f-e053-2a91aa0a26b22026-02-11WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.