FDA.reportPublic FDA data

Budesonide

Product NDC
0487-9701
11-digit product format
004879701
Labeler code
0487
Product ID
0487-9701_32635b5d-cc62-710c-e063-6294a90a2802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUDESONIDE
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
ANDA078202
Marketing category
ANDA
Marketing start
2013-10-01
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
Rxcui349094, 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
0487-9701-01Budesonide6 in 1 CARTONINHALANT68
0487-9701-01Budesonide5 in 1 POUCHINHALANT58
0487-9701-30Budesonide30 in 1 CARTONINHALANT308
0487-9701-30Budesonide1 in 1 POUCHINHALANT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9701-01ML - Milliliter0487-97013c4d0c41-7fa0-4b53-ac4e-58b3cb02fa6212016-07-19
0487-9701-30ML - Milliliter0487-9701cd80e668-ef96-4fa5-b3e5-e6dcb9bf726912016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1
WaterINACTIVE INGREDIENT059QF0KO0RBUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9701BUDESONIDE INHALANT [NEPHRON PHARMACEUTICALS CORPORATION]8Current NDC, Legacy NDC, 4 package rows20250411_f12043df-f9a3-4edb-88f8-dd176c1a141c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNf12043df-f9a3-4edb-88f8-dd176c1a141c8
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNf12043df-f9a3-4edb-88f8-dd176c1a141c8
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDf12043df-f9a3-4edb-88f8-dd176c1a141c8
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDf12043df-f9a3-4edb-88f8-dd176c1a141c8
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYf12043df-f9a3-4edb-88f8-dd176c1a141c8
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYf12043df-f9a3-4edb-88f8-dd176c1a141c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-9701-01004879701016 POUCH in 1 CARTON (0487-9701-01) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE6 pouch2013-10-010000-00-00NoNoCurrent
0487-9701-300048797013030 POUCH in 1 CARTON (0487-9701-30) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE30 pouch2013-10-010000-00-00NoNoCurrent