FDA.reportPublic FDA data

Budesonide Inhalation

Product NDC
0115-1689
11-digit product format
001151689
Labeler code
0115
Product ID
0115-1689_dbb6c949-66b1-4f60-ab96-442dd8b4ea19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA078404
Marketing category
ANDA
Marketing start
2016-08-04
Substance
BUDESONIDE
Active strength
.5 mg/2mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Budesonide Inhalation
Listing expiration
2027-12-31

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
0115-1689-74Budesonide Inhalation6 in 1 CARTONSUSPENSION612
0115-1689-76Budesonide Inhalation5 in 1 POUCHSUSPENSION512
0115-1689-76Budesonide Inhalation2 mL in 1 VIALSUSPENSION212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1689-74ML - Milliliter0115-168938f97160-69bd-4260-aec6-3d8b17e716ae12017-12-14
0115-1689-76ML - Milliliter0115-16892436323f-faed-4aa8-a7e7-479e2780a41212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1689BUDESONIDE INHALATION (BUDESONIDE) SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]11Current NDC, Legacy NDC, 3 package rows20231231_e8ef9489-83a2-4817-b21c-ea3fecd8c8dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349094budesonide 0.25 MG in 2 ML Inhalation SuspensionPSNe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12
349094budesonide 0.125 MG/ML Inhalation SuspensionSCDe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12
349094budesonide 0.25 MG per 2 ML Inhalation SuspensionSYe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYe8ef9489-83a2-4817-b21c-ea3fecd8c8dd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1689-74001151689746 POUCH in 1 CARTON (0115-1689-74) / 5 VIAL in 1 POUCH (0115-1689-76) / 2 mL in 1 VIAL6 pouch2016-08-040000-00-00NoNoCurrent
0115-1689-76001151689765 in 1 POUCHHistorical