Budesonide

Product NDC: 46122-389
11-digit product format: 461220389
Labeler code: 46122
Product ID: 46122-389_6cbd5b0f-8a4c-f704-98fc-42f657057972
Type: HUMAN OTC DRUG
Nonproprietary name: Budesonide
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Amerisource Bergen
Application: ANDA078949
Marketing category: ANDA
Marketing start: 2016-09-15
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 32 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	46122-389		D	Discontinued by firm		2026-08-11
excluded package	package	46122-389	46122-389-76	D	Discontinued by firm		2026-08-11

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	46122-389		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46122-389	46122-389-76	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078949-002	BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL			2015-11-20

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-389-76	ML - Milliliter	46122-389	6542cd36-e98b-43fd-b330-dbf7240428dd	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-389	BUDESONIDE SPRAY, METERED [AMERISOURCE BERGEN]	7	Legacy NDC	20241004_ab2e6644-912c-7d39-8ee4-039152ee3db2.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Rugby Laboratories	04eb9e98-1323-353f-3fd7-2d317dfac526	2026-02-27	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	Walgreens	9d519bf3-8d9b-5208-13c5-308edc24aca7	2026-01-21	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	CVS Pharmacy	b2650d29-c011-48f1-a7f4-040011d4563d	2026-01-21	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	Rugby Laboratories	b83af99e-1619-48ed-a033-e5207033f77e	2025-12-09	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	Apotex Corp.	f1aac35a-bc72-dd68-8179-8661354589cb	2025-09-22	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949
Budesonide	BUDESONIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d9ba3859-90af-0390-11be-c04834e27d61	2025-05-16	Warnings	Exact identifier application applno (ANDA): 078949 application number: ANDA078949

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	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-389-76	46122038976	1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (46122-389-76) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2016-09-15	0000-00-00	No	No	Current