FDA.reportPublic FDA data

budesonide inhalation

Product NDC
68180-984
11-digit product format
681800984
Labeler code
68180
Product ID
68180-984_3315e8ee-f729-4dab-86e4-349ab1c9c9ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
budesonide inhalation
Dosage form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210897
Marketing category
ANDA
Marketing start
2019-05-21
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
68180-984-30budesonide inhalation6 in 1 CARTONSUSPENSION67
68180-984-30budesonide inhalation5 in 1 POUCHSUSPENSION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-984-05ML - Milliliter68180-984771db015-c9e4-49ca-a3c2-84b7688139b512019-06-19
68180-984-30ML - Milliliter68180-984003cc16f-51ff-41bf-83a3-a4de98bbae5812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-984BUDESONIDE INHALATION SUSPENSION [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20250124_944cbb7c-b41d-4a6d-8a93-2e646365c982.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN944cbb7c-b41d-4a6d-8a93-2e646365c9827
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD944cbb7c-b41d-4a6d-8a93-2e646365c9827
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY944cbb7c-b41d-4a6d-8a93-2e646365c9827
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
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSN87048fa9-3391-4f30-801d-b96ca0132f564
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNd2178406-9d1b-e0e0-e053-2a95a90a16be4
351109budesonide 0.5 MG in 2 ML Inhalation SuspensionPSNdd74e446-7c1b-4f02-9c73-ba716572ee774
351109budesonide 0.25 MG/ML Inhalation SuspensionSCD87048fa9-3391-4f30-801d-b96ca0132f564
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDd2178406-9d1b-e0e0-e053-2a95a90a16be4
351109budesonide 0.25 MG/ML Inhalation SuspensionSCDdd74e446-7c1b-4f02-9c73-ba716572ee774
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSY87048fa9-3391-4f30-801d-b96ca0132f564
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYd2178406-9d1b-e0e0-e053-2a95a90a16be4
351109budesonide 0.5 MG per 2 ML Inhalation SuspensionSYdd74e446-7c1b-4f02-9c73-ba716572ee774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-984-30681800984306 POUCH in 1 CARTON (68180-984-30) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE6 pouch2019-05-210000-00-00NoNoCurrent