FDA.reportPublic FDA data

NDC 51079-020-01 - 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
51079-020
Requested NDC
51079-020-01
Package NDCs from labels
51079-020-01, 51079-020-03
Manufacturer
Mylan Institutional Inc.
Effective date
2021-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Budesonide - Mylan Institutional Inc.Mylan Institutional Inc.2021-12-21HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-020-01EA - Each51079-0202bdb6a74-9e55-42f3-bced-9ad3e1267fa312012-07-24
51079-020-03EA - Each51079-020479af571-ed2b-478e-b2a4-b5d2b4d45aa212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUDESONIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2

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 1 of 173 · 3,447 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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