FDA.reportPublic FDA data

PULMICORT

Product NDC
85612-011
11-digit product format
856120011
Labeler code
85612
Product ID
85612-011_a035bb8f-2fe9-4a86-af53-32196ffc0361
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
AEROSOL, POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Rubicon Holdings Inc.
Application
NDA021949
Marketing category
NDA
Marketing start
2025-07-01
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, 966527, 966529

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
85612-011-01PULMICORTFLEXHALER120 in 1 INHALERAEROSOL, POWDER1202
85612-011-01PULMICORTFLEXHALER1 in 1 CARTONAEROSOL, POWDER12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85612-011-01EA - Each85612-0111aa24afe-0c95-419a-8009-321bb622f95e12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966522budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSNae1105cd-69fc-4c15-937f-c535304341c22
966522budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966527budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSNae1105cd-69fc-4c15-937f-c535304341c22
966524Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSN5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966524Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUATPSNae1105cd-69fc-4c15-937f-c535304341c22
966529Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSNae1105cd-69fc-4c15-937f-c535304341c22
966524120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBD5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966524120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBDae1105cd-69fc-4c15-937f-c535304341c22
96652960 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBDae1105cd-69fc-4c15-937f-c535304341c22
966522120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder InhalerSCD5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966522120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder InhalerSCDae1105cd-69fc-4c15-937f-c535304341c22
96652760 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder InhalerSCDae1105cd-69fc-4c15-937f-c535304341c22
966527budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966522budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966522budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966522budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSSYae1105cd-69fc-4c15-937f-c535304341c22
966522budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSSY5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966527budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966529Pulmicort 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966529Pulmicort Flexhaler 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966524Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966524Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUATSY5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662
966524Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSYae1105cd-69fc-4c15-937f-c535304341c22
966524Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATSY5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85612-011-01856120011011 INHALER in 1 CARTON (85612-011-01) / 120 AEROSOL, POWDER in 1 INHALER1 inhaler2025-07-01NoNoHistorical