Budesonide

Product NDC: 68788-7290
11-digit product format: 687887290
Labeler code: 68788
Product ID: 68788-7290_95bfc13d-d92a-4d98-a328-890337d95556
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: INHALANT
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA205710
Marketing category: ANDA
Marketing start: 2019-01-21
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 0 mg/2mL
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	68788-7290		D	Discontinued by firm		2026-08-17
excluded package	package	68788-7290	68788-7290-3	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205710-001	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16
A205710-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16
A205710-003	BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205710-001	AN
A205710-002	AN
A205710-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-003	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205710-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2017-11-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205710-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-002	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205710-003	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205710-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-002	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205710-003	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-002	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205710-003	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205710-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-002	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205710-003	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-002	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205710-003	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205710-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205710-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205710-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205710-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205710-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205710-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205710-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205710-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205710-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205710-001	AN	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7290-3	ML - Milliliter	68788-7290	aea882b1-6699-48e3-b064-3305ed990919	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7290	BUDESONIDE INHALATION SUSPENSION (BUDESONIDE) INHALANT [PREFERRED PHARMACEUTICALS INC.]	7	Legacy NDC	20250210_61b907a0-80f4-4a46-8d5b-29c2eedaa17a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide Inhalation Suspension	BUDESONIDE	Cipla USA Inc.	c52c5382-1400-44b9-95be-a30e1cf706da	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710
Budesonide Inhalation Suspension	BUDESONIDE	Preferred Pharmaceuticals Inc.	dcb35488-23c5-4e7b-ab86-8406cf855748	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710
Budesonide Inhalation Suspension	BUDESONIDE	Exelan Pharmaceuticals, Inc.	d9656442-4587-4867-9a8c-5f5b0402936e	2020-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205710 application number: ANDA205710

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
68788-7290-3	68788729003	6 POUCH in 1 CARTON (68788-7290-3) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE	6 pouch	2019-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide Inhalation Suspension	Preferred Pharmaceuticals Inc.	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	7