Budesonide

Product NDC: 64980-638
11-digit product format: 649800638
Labeler code: 64980
Product ID: 64980-638_325091e2-1d97-4321-e063-6394a90ae5f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUDESONIDE
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078202
Marketing category: ANDA
Marketing start: 2025-03-14
Substance: BUDESONIDE
Active strength: .25 mg/2mL
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 42.

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 · 84 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	A078202-001	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078202-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2009-03-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078202-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078202-002	AN	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Budesonide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	.25 mg/2mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349094	Internal RxNorm lookup
351109	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
3235e2a4-8e12-2d58-e063-6294a90a4936	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
64980-638-03	Budesonide	5 in 1 POUCH	INHALANT	5		2
64980-638-03	Budesonide	30 in 1 CARTON	INHALANT	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-638-03	ML - Milliliter	64980-638	be6e7920-baff-4496-b7e5-f423ce7cf764	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-638	BUDESONIDE INHALANT [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 2 package rows	20250411_3235e2a4-8e12-2d58-e063-6294a90a4936.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 · 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 ndc (product): 64980-638
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349094	budesonide 0.25 MG in 2 ML Inhalation Suspension	PSN	3235e2a4-8e12-2d58-e063-6294a90a4936	2
351109	budesonide 0.5 MG in 2 ML Inhalation Suspension	PSN	3235e2a4-8e12-2d58-e063-6294a90a4936	2
349094	budesonide 0.125 MG/ML Inhalation Suspension	SCD	3235e2a4-8e12-2d58-e063-6294a90a4936	2
351109	budesonide 0.25 MG/ML Inhalation Suspension	SCD	3235e2a4-8e12-2d58-e063-6294a90a4936	2
349094	budesonide 0.25 MG per 2 ML Inhalation Suspension	SY	3235e2a4-8e12-2d58-e063-6294a90a4936	2
351109	budesonide 0.5 MG per 2 ML Inhalation Suspension	SY	3235e2a4-8e12-2d58-e063-6294a90a4936	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-638-03	64980063803	30 POUCH in 1 CARTON (64980-638-03) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE	30 pouch	2025-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	Rising Pharma Holdings, Inc. \| Nephron SC, LLC	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	3