PULMICORT

Product NDC: 85612-011
Requested package NDC: 85612-011-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021949-001	PULMICORT FLEXHALER	BUDESONIDE	0.08MG/INH	POWDER, METERED / INHALATION		RLD, RS	2006-07-12
N021949-002	PULMICORT FLEXHALER	BUDESONIDE	0.16MG/INH	POWDER, METERED / INHALATION		RLD, RS	2006-07-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021949-001	PULMICORT FLEXHALER	0.08MG/INH	POWDER, METERED / INHALATION	RLD	2006-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021949-002	PULMICORT FLEXHALER	0.16MG/INH	POWDER, METERED / INHALATION	RLD, RS	2006-07-12	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: PULMICORT
Brand name suffix: FLEXHALER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	180 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966522	Internal RxNorm lookup
966524	Internal RxNorm lookup
966527	Internal RxNorm lookup
966529	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ae1105cd-69fc-4c15-937f-c535304341c2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85612-011-01	PULMICORTFLEXHALER	120 in 1 INHALER	AEROSOL, POWDER	120		2
85612-011-01	PULMICORTFLEXHALER	1 in 1 CARTON	AEROSOL, POWDER	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85612-011-01	EA - Each	85612-011	1aa24afe-0c95-419a-8009-321bb622f95e	1	2025-10-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	Rubicon Holdings Inc.	ae1105cd-69fc-4c15-937f-c535304341c2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949 ndc (package): 85612-011-01 ndc (product): 85612-011 ndc11 (package): 85612001101
PULMICORT FLEXHALER	BUDESONIDE	H2-Pharma LLC	10f2ae5b-a6fb-4804-9111-0cd067c2b1b2	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	10ea5d87-6ed0-4fa5-a37b-2043c8560bc0	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949
PULMICORT FLEXHALER	BUDESONIDE	A-S Medication Solutions	79fc8cf4-bb33-4892-9dd2-641d7e943a01	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021949 application number: NDA021949

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966522	budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	ae1105cd-69fc-4c15-937f-c535304341c2	2
966522	budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966527	budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	ae1105cd-69fc-4c15-937f-c535304341c2	2
966524	Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966524	Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	ae1105cd-69fc-4c15-937f-c535304341c2	2
966529	Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT	PSN	ae1105cd-69fc-4c15-937f-c535304341c2	2
966524	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]	SBD	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966524	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]	SBD	ae1105cd-69fc-4c15-937f-c535304341c2	2
966529	60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler [Pulmicort]	SBD	ae1105cd-69fc-4c15-937f-c535304341c2	2
966522	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler	SCD	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966522	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler	SCD	ae1105cd-69fc-4c15-937f-c535304341c2	2
966527	60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler	SCD	ae1105cd-69fc-4c15-937f-c535304341c2	2
966527	budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966522	budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966522	budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966522	budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966522	budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS	SY	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966527	budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966529	Pulmicort 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966529	Pulmicort Flexhaler 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966524	Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966524	Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2
966524	Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT	SY	ae1105cd-69fc-4c15-937f-c535304341c2	2
966524	Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT	SY	5d0c6c7e-2f53-4238-ab34-bd8cf49d8a66	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85612-011-01	85612001101	1 INHALER in 1 CARTON (85612-011-01) / 120 AEROSOL, POWDER in 1 INHALER	1 inhaler	2025-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PULMICORT FLEXHALER - A-S Medication Solutions	A-S Medication Solutions	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	2
PULMICORT FLEXHALER - Rubicon Holdings Inc.	Rubicon Holdings Inc.	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	3