Budesonide

Product NDC: 0536-1456
11-digit product format: 005361456
Labeler code: 0536
Product ID: 0536-1456_5592d8c7-a130-4ec6-8b15-9329daeb91c7
Type: HUMAN OTC DRUG
Nonproprietary name: Budesonide
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Rugby Laboratories
Application: ANDA078949
Marketing category: ANDA
Marketing start: 2025-12-01
Substance: BUDESONIDE
Active strength: 32 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Budesonide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	32 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797929	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b83af99e-1619-48ed-a033-e5207033f77e	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1456-84	Budesonide	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120		2
0536-1456-84	Budesonide	1 in 1 CARTON	SPRAY, METERED	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1456-84	ML - Milliliter	0536-1456	7fffb16f-667e-43b4-b239-2d98185e7b15	1	2025-12-16

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 ndc (product): 0536-1456
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	PSN	b83af99e-1619-48ed-a033-e5207033f77e	2
1797929	budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray	SCD	b83af99e-1619-48ed-a033-e5207033f77e	2
1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	SY	b83af99e-1619-48ed-a033-e5207033f77e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0536-1456-84	00536145684	1 BOTTLE, SPRAY in 1 CARTON (0536-1456-84) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2025-12-01	No	No	Current