FDA.reportPublic FDA data

PULMICORT

Product NDC
50090-2239
11-digit product format
500902239
Labeler code
50090
Product ID
50090-2239_eec30382-8d42-4d25-8e67-cae942268c30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
AEROSOL, POWDER
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021949
Marketing category
NDA
Marketing start
2007-03-19
Substance
BUDESONIDE
Active strength
180 ug/1
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
PULMICORT
Brand name suffix
FLEXHALER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE180 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui966522, 966524

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2239-02023-02-07C16284748780-1f386c649-eacf-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 2006
50090-2239-02023-01-30C16284748780-1f386c649-eacf-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PULMICORT FLEXHALER™ safely and effectively. See full prescribing information for PULMICORT FLEXHALER . PULMICORT FLEXHALER™ (budesonide) inhalation powder Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2239-0PULMICORTFLEXHALER1 in 1 CARTONAEROSOL, POWDER110
50090-2239-0PULMICORTFLEXHALER120 in 1 INHALERAEROSOL, POWDER12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2239-0EA - Each50090-2239216f29d2-9b78-49e5-84c5-a6a1de2f404f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2239PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20230208_79fc8cf4-bb33-4892-9dd2-641d7e943a01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966522budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966524Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966524120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBD79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966522120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder InhalerSCD79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966522budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966522budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSSY79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966524Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY79fc8cf4-bb33-4892-9dd2-641d7e943a0110
966524Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSY79fc8cf4-bb33-4892-9dd2-641d7e943a0110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2239-0500902239001 INHALER in 1 CARTON (50090-2239-0) / 120 AEROSOL, POWDER in 1 INHALER1 inhaler2015-11-230000-00-00NoNoCurrent