FDA.reportPublic FDA data

Budesonide Inhalation

Product NDC
60687-524
11-digit product format
606870524
Labeler code
60687
Product ID
60687-524_3765f418-7255-94d8-e063-6394a90ab595
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide Inhalation
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA210897
Marketing category
ANDA
Marketing start
2020-01-06
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 Inhalation
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE.5 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui351109

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-524-79Budesonide Inhalation1 in 1 POUCHSUSPENSION15
60687-524-79Budesonide Inhalation2 mL in 1 AMPULESUSPENSION25
60687-524-83Budesonide Inhalation30 in 1 CARTONSUSPENSION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-524-79ML - Milliliter60687-52470b3203a-f74c-41e4-8443-e46798cca20712020-01-03
60687-524-83ML - Milliliter60687-524cd5818d3-3f33-40a5-9e7f-779cbdfce62612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-524BUDESONIDE INHALATION SUSPENSION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240731_45e5f304-1177-42a2-91c9-3ed1a9c9f8e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN45e5f304-1177-42a2-91c9-3ed1a9c9f8e65
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD45e5f304-1177-42a2-91c9-3ed1a9c9f8e65
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY45e5f304-1177-42a2-91c9-3ed1a9c9f8e65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-524-79606870524791 in 1 POUCHHistorical
60687-524-836068705248330 POUCH in 1 CARTON (60687-524-83) / 1 AMPULE in 1 POUCH (60687-524-79) / 2 mL in 1 AMPULE30 pouch2020-01-060000-00-00NoNoCurrent