FDA.reportPublic FDA data

Budesonide

Product NDC
0781-7516
11-digit product format
007817516
Labeler code
0781
Product ID
0781-7516_89c0a36a-04f4-458f-8518-6a9a92168b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Sandoz Inc
Application
ANDA201966
Marketing category
ANDA
Marketing start
2015-07-24
Substance
BUDESONIDE
Active strength
.5 mg/2mL
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
BUDESONIDE.5 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui252559, 349094, 351109

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
0781-7516-14Budesonide5 in 1 POUCHSUSPENSION54
0781-7516-72Budesonide2 mL in 1 AMPULESUSPENSION24
0781-7516-87Budesonide6 in 1 CARTONSUSPENSION64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7516-14ML - Milliliter0781-75160d900ed2-36ae-43cf-b780-a8c25f56e2a412016-12-07
0781-7516-87ML - Milliliter0781-751660f59260-ca53-4827-a4cf-b256b4f3f9bb12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE SUSPENSION [SANDOZ INC]1
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE SUSPENSION [SANDOZ INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUDESONIDE SUSPENSION [SANDOZ INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBUDESONIDE SUSPENSION [SANDOZ INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE SUSPENSION [SANDOZ INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUDESONIDE SUSPENSION [SANDOZ INC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KBUDESONIDE SUSPENSION [SANDOZ INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBUDESONIDE SUSPENSION [SANDOZ INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7516BUDESONIDE SUSPENSION [SANDOZ INC]3Current NDC, Legacy NDC, 3 package rows20200407_4830c0dd-6964-4108-89bc-3af039612b95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSN4830c0dd-6964-4108-89bc-3af039612b954
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN4830c0dd-6964-4108-89bc-3af039612b954
252559budesonide 1 MG in 2 ML Inhalation SuspensionPSN4830c0dd-6964-4108-89bc-3af039612b954
349094budesonide 0.125 MG/ML Inhalation SuspensionSCD4830c0dd-6964-4108-89bc-3af039612b954
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD4830c0dd-6964-4108-89bc-3af039612b954
252559budesonide 0.5 MG/ML Inhalation SuspensionSCD4830c0dd-6964-4108-89bc-3af039612b954
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSY4830c0dd-6964-4108-89bc-3af039612b954
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY4830c0dd-6964-4108-89bc-3af039612b954
252559budesonide 1 MG per 2 ML Inhalation SuspensionSY4830c0dd-6964-4108-89bc-3af039612b954

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-7516-14007817516145 in 1 POUCHHistorical
0781-7516-72007817516722 mL in 1 AMPULE2 mlHistorical
0781-7516-87007817516876 POUCH in 1 CARTON (0781-7516-87) / 5 AMPULE in 1 POUCH (0781-7516-14) / 2 mL in 1 AMPULE (0781-7516-72) 6 pouch2015-07-240000-00-00NoNoCurrent