PULMICORT

Product NDC: 0186-0916
11-digit product format: 001860916
Labeler code: 0186
Product ID: 0186-0916_62af6940-7a80-400c-b2e7-e7d6145df756
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: AEROSOL, POWDER
Route: RESPIRATORY (INHALATION)
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA021949
Marketing category: NDA
Marketing start: 2007-03-19
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 180 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0186-0916		D	Discontinued by firm		2026-08-10
excluded package	package	0186-0916	0186-0916-12	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0186-0916		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0186-0916	0186-0916-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0186-0916-12	EA - Each	0186-0916	9f224ee3-2984-48c4-b1ac-16d47cf9520c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP]	14
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP]	14
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA LP]	14
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [PHYSICIANS TOTAL CARE, INC.]	2
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0186-0916	PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [ASTRAZENECA PHARMACEUTICALS LP]	26	Legacy NDC	20230826_54234b7d-3bcc-4809-1881-1d21484856a0.zip

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
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	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966524	Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966524	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]	SBD	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966522	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler	SCD	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966522	budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966522	budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS	SY	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966524	Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966524	Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT	SY	79fc8cf4-bb33-4892-9dd2-641d7e943a01	10
966522	budesonide 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966524	Pulmicort Flexhaler 180 MCG/INHAL Dry Powder Inhaler, 120 ACTUAT	PSN	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966524	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler [Pulmicort]	SBD	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966522	120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler	SCD	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966522	budesonide 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966522	budesonide 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUATS	SY	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966524	Pulmicort Flexhaler 0.18 MG/ACTUAT (0.16 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 120 ACTUAT	SY	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2
966524	Pulmicort Flexhaler 180 MCG/ACTUAT Dry Powder Inhaler, 120 ACTUAT	SY	cf2c0eb4-f95a-465c-b7e4-e0b3c06924bb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0186-0916-12	00186091612	1 INHALER in 1 CARTON (0186-0916-12) > 120 AEROSOL, POWDER in 1 INHALER	1 inhaler	2007-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PULMICORT FLEXHALER - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	10
PULMICORT FLEXHALER - AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2019-10-11	HUMAN PRESCRIPTION DRUG LABEL	26
PULMICORT FLEXHALER - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-06-04	HUMAN PRESCRIPTION DRUG LABEL	2