Budesonide

Product NDC: 60505-0820
11-digit product format: 605050820
Labeler code: 60505
Product ID: 60505-0820_19e56efe-5076-e888-4634-1fcff544a418
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: Apotex Corp.
Application: ANDA078202
Marketing category: ANDA
Marketing start: 2009-03-30
Marketing end: 2021-06-20
Substance: BUDESONIDE
Active strength: 0 mg/2mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	60505-0820		D	Discontinued by firm		2026-08-03
excluded package	package	60505-0820	60505-0820-0	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-0820-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-0820-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-0820-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-0820-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-0820-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-0820-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-0820-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-0820-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-0820-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-0820-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-0820-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-0820-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078202-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN		2009-03-30
A078202-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2009-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078202-001	AN
A078202-002	AN

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078202-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078202-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078202-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078202-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078202-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078202-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078202-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078202-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078202-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078202-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078202-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078202-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078202-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078202-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078202-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078202-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078202-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078202-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078202-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078202-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078202-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078202-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078202-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078202-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078202-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078202-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078202-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078202-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078202-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078202-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078202-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078202-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078202-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078202-002	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078202-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078202-002	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078202-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078202-002	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078202-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078202-002	AN	1	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
Budesonide	ACTIVE MOIETY	Q3OKS62Q6X	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUDESONIDE SUSPENSION [APOTEX CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUDESONIDE SUSPENSION [APOTEX CORP.]	2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Rising Pharma Holdings, Inc.	3235e2a4-8e12-2d58-e063-6294a90a4936	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078202 application number: ANDA078202
Budesonide	BUDESONIDE	Nephron Pharmaceuticals Corporation	f12043df-f9a3-4edb-88f8-dd176c1a141c	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078202 application number: ANDA078202
Budesonide	BUDESONIDE	A-S Medication Solutions	521a79d0-4d93-45f7-8feb-8d2b502dd216	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078202 application number: ANDA078202
Budesonide	BUDESONIDE	Chartwell RX, LLC	374013c9-18c9-4419-b9fb-9bc5c765688e	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078202 application number: ANDA078202

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0820-0	60505082000	30 AMPULE in 1 CARTON (60505-0820-0) > 2 mL in 1 AMPULE	30 ampule	2009-03-30	2021-06-20	No	No	Current