FDA.reportPublic FDA data

PULMICORT FLEXHALER

Product NDC
50090-6796
11-digit product format
500906796
Labeler code
50090
Product ID
50090-6796_ce8a32cf-d41e-4ffa-a5b0-61b6f78d49cb
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6796-0PULMICORT FLEXHALER1 in 1 CARTONAEROSOL, POWDER12
50090-6796-0PULMICORT FLEXHALER120 in 1 INHALERAEROSOL, POWDER1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6796-0EA - Each50090-67965ec672d7-c32f-4699-9867-10d9d7bb922812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6796PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20231109_10ea5d87-6ed0-4fa5-a37b-2043c8560bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966522budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966524Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966524120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBD10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966522120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder InhalerSCD10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966522budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966522budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSSY10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966524Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY10ea5d87-6ed0-4fa5-a37b-2043c8560bc02
966524Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSY10ea5d87-6ed0-4fa5-a37b-2043c8560bc02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6796-0500906796001 INHALER in 1 CARTON (50090-6796-0) / 120 AEROSOL, POWDER in 1 INHALER1 inhaler2023-11-01NoNoCurrent