Budesonide Inhalation Suspension

Product NDC: 76204-018
Requested package NDC: 76204-018-01
11-digit product format: 762040018
Labeler code: 76204
Product ID: 76204-018_eff7eb41-672a-5ed3-e053-2a95a90a35d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide Inhalation Suspension
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: Ritedose Pharmaceuticals, LLC
Application: ANDA210897
Marketing category: ANDA
Marketing start: 2021-12-01
Marketing end: 0000-00-00
Substance: BUDESONIDE
Active strength: 1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76204-018	76204-018-01	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A210897-001	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2018-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210897-001	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 2 · 42 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	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A210897-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210897-001	AN	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76204-018-01	2024-01-30	C162847	48780-1	1030e365-39b6-111a-e063-dadaa90a10e2	Budesonide Inhalation Suspension These highlights do not include all the information needed to use BUDESONIDE INHALATION SUSPENSION safely and effectively. See full prescribing information for BUDESONIDE INHALATION SUSPENSION. BUDESONIDE inhalation suspension. Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76204-018-01	Budesonide Inhalation Suspension	1 in 1 CARTON	SUSPENSION	1	4
76204-018-11	Budesonide Inhalation Suspension	5 mL in 1 AMPULE	SUSPENSION	5	4
76204-018-11	Budesonide Inhalation Suspension	30 in 1 POUCH	SUSPENSION	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76204-018-01	ML - Milliliter	76204-018	db8aa0b8-e9c3-4c26-8a5b-664e5ce01746	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76204-018	BUDESONIDE INHALATION SUSPENSION SUSPENSION [RITEDOSE PHARMACEUTICALS, LLC]	4	Legacy NDC, 3 package rows	20221217_d2178406-9d1b-e0e0-e053-2a95a90a16be.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 inhalation	BUDESONIDE INHALATION	Preferred Pharmaceuticals, Inc.	dd74e446-7c1b-4f02-9c73-ba716572ee77	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
Budesonide Inhalation	BUDESONIDE INHALATION	American Health Packaging	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
budesonide inhalation	BUDESONIDE INHALATION	A-S Medication Solutions	87048fa9-3391-4f30-801d-b96ca0132f56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
budesonide inhalation	BUDESONIDE INHALATION	Lupin Pharmaceuticals, Inc.	944cbb7c-b41d-4a6d-8a93-2e646365c982	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897

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
351109	budesonide 0.5 MG in 2 ML Inhalation Suspension	PSN	d2178406-9d1b-e0e0-e053-2a95a90a16be	4
351109	budesonide 0.25 MG/ML Inhalation Suspension	SCD	d2178406-9d1b-e0e0-e053-2a95a90a16be	4
351109	budesonide 0.5 MG per 2 ML Inhalation Suspension	SY	d2178406-9d1b-e0e0-e053-2a95a90a16be	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76204-018-01	76204001801	1 POUCH in 1 CARTON (76204-018-01) > 30 AMPULE in 1 POUCH (76204-018-11) > 5 mL in 1 AMPULE	1 pouch	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide Inhalation Suspension	Ritedose Pharmaceuticals, LLC \| The Ritedose Corporation	2022-12-16	HUMAN PRESCRIPTION DRUG LABEL	4