PULMICORT

Product NDC
21695-291
11-digit product format
216950291
Labeler code
21695
Product ID
21695-291_0950cd08-a48b-4376-9647-da22cf5a8a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Budesonide
Dosage form
AEROSOL, POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp
Application
NDA021949
Marketing category
NDA
Marketing start
2010-07-30
Marketing end
0000-00-00
Substance
BUDESONIDE
Active strength
90 ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-291IInactivated by FDA2026-08-10
excluded packagepackage21695-29121695-291-01IInactivated by FDA2026-08-10

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-291-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-291-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-291-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-291-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-291-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-291-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-291-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-291-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-291-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-291-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-291-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-291-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-291-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-291-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-291-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-291-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-291-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-291-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-291-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-291-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-291-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-291-01110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021949-001PULMICORT FLEXHALERBUDESONIDE0.08MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12
N021949-002PULMICORT FLEXHALERBUDESONIDE0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021949-001PULMICORT FLEXHALER0.08MG/INHPOWDER, METERED / INHALATIONRLD2006-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N021949-002PULMICORT FLEXHALER0.16MG/INHPOWDER, METERED / INHALATIONRLD, RS2006-07-12782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-291-01PULMICORTFLEXHALER1 in 1 CARTONAEROSOL, POWDER11
21695-291-01PULMICORTFLEXHALER60 in 1 INHALERAEROSOL, POWDER601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-291-01EA - Each21695-2914d235de4-f88b-42cc-bf9c-bc91ff33ee9812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-291PULMICORT FLEXHALER (BUDESONIDE) AEROSOL, POWDER [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110908_0950cd08-a48b-4376-9647-da22cf5a8a70.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PULMICORT FLEXHALERBUDESONIDEA-S Medication Solutions5d0c6c7e-2f53-4238-ab34-bd8cf49d8a662026-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021949
application number: NDA021949
PULMICORT FLEXHALERBUDESONIDERubicon Holdings Inc.ae1105cd-69fc-4c15-937f-c535304341c22025-09-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021949
application number: NDA021949
PULMICORT FLEXHALERBUDESONIDEH2-Pharma LLC10f2ae5b-a6fb-4804-9111-0cd067c2b1b22025-01-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021949
application number: NDA021949
PULMICORT FLEXHALERBUDESONIDEA-S Medication Solutions10ea5d87-6ed0-4fa5-a37b-2043c8560bc02023-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 021949
application number: NDA021949
PULMICORT FLEXHALERBUDESONIDEA-S Medication Solutions79fc8cf4-bb33-4892-9dd2-641d7e943a012023-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021949
application number: NDA021949

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966527budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN0950cd08-a48b-4376-9647-da22cf5a8a701
966529Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUATPSN0950cd08-a48b-4376-9647-da22cf5a8a701
96652960 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler [Pulmicort]SBD0950cd08-a48b-4376-9647-da22cf5a8a701
96652760 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder InhalerSCD0950cd08-a48b-4376-9647-da22cf5a8a701
966527budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSY0950cd08-a48b-4376-9647-da22cf5a8a701
966527budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY0950cd08-a48b-4376-9647-da22cf5a8a701
966529Pulmicort 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY0950cd08-a48b-4376-9647-da22cf5a8a701
966529Pulmicort Flexhaler 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUATSY0950cd08-a48b-4376-9647-da22cf5a8a701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-291-01216950291011 in 1 CARTONHistorical