Budesonide

Product NDC: 0781-7516
Requested package NDC: 0781-7516-87
11-digit product format: 007817516
Labeler code: 0781
Product ID: 0781-7516_89c0a36a-04f4-458f-8518-6a9a92168b2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: Sandoz Inc
Application: ANDA201966
Marketing category: ANDA
Marketing start: 2015-07-24
Substance: BUDESONIDE
Active strength: .5 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

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	0781-7516	0781-7516-87	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A201966-001	BUDESONIDE	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	2013-09-27
A201966-002	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	2013-09-27
A201966-003	BUDESONIDE	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	2013-09-27

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION		2013-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-002	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-003	BUDESONIDE	0.25MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201966-001	BUDESONIDE	1MG/2ML	SUSPENSION / INHALATION	AN	2013-09-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201966-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201966-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201966-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201966-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201966-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201966-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201966-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201966-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201966-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-002	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201966-003	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201966-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201966-002	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201966-003	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201966-003	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201966-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201966-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201966-003	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201966-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201966-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201966-003	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201966-001	AN	1	`74a2ff9319b5…`

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	SPL version
0781-7516-14	Budesonide	5 in 1 POUCH	SUSPENSION	5	4
0781-7516-72	Budesonide	2 mL in 1 AMPULE	SUSPENSION	2	4
0781-7516-87	Budesonide	6 in 1 CARTON	SUSPENSION	6	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-7516-14	ML - Milliliter	0781-7516	0d900ed2-36ae-43cf-b780-a8c25f56e2a4	1	2016-12-07
0781-7516-87	ML - Milliliter	0781-7516	60f59260-ca53-4827-a4cf-b256b4f3f9bb	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	BUDESONIDE SUSPENSION [SANDOZ INC]	1
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	BUDESONIDE SUSPENSION [SANDOZ INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BUDESONIDE SUSPENSION [SANDOZ INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BUDESONIDE SUSPENSION [SANDOZ INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUDESONIDE SUSPENSION [SANDOZ INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	BUDESONIDE SUSPENSION [SANDOZ INC]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	BUDESONIDE SUSPENSION [SANDOZ INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUDESONIDE SUSPENSION [SANDOZ INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-7516	BUDESONIDE SUSPENSION [SANDOZ INC]	3	Current NDC, Legacy NDC, 3 package rows	20200407_4830c0dd-6964-4108-89bc-3af039612b95.zip

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	4830c0dd-6964-4108-89bc-3af039612b95	4
351109	budesonide 0.5 MG in 2 ML Inhalation Suspension	PSN	4830c0dd-6964-4108-89bc-3af039612b95	4
252559	budesonide 1 MG in 2 ML Inhalation Suspension	PSN	4830c0dd-6964-4108-89bc-3af039612b95	4
349094	budesonide 0.125 MG/ML Inhalation Suspension	SCD	4830c0dd-6964-4108-89bc-3af039612b95	4
351109	budesonide 0.25 MG/ML Inhalation Suspension	SCD	4830c0dd-6964-4108-89bc-3af039612b95	4
252559	budesonide 0.5 MG/ML Inhalation Suspension	SCD	4830c0dd-6964-4108-89bc-3af039612b95	4
349094	budesonide 0.25 MG per 2 ML Inhalation Suspension	SY	4830c0dd-6964-4108-89bc-3af039612b95	4
351109	budesonide 0.5 MG per 2 ML Inhalation Suspension	SY	4830c0dd-6964-4108-89bc-3af039612b95	4
252559	budesonide 1 MG per 2 ML Inhalation Suspension	SY	4830c0dd-6964-4108-89bc-3af039612b95	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-7516-87	00781751687	6 POUCH in 1 CARTON (0781-7516-87) / 5 AMPULE in 1 POUCH (0781-7516-14) / 2 mL in 1 AMPULE (0781-7516-72)	6 pouch	2015-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	Sandoz Inc	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	4
Budesonide	Preferred Pharmaceuticals Inc.	2019-06-20	HUMAN PRESCRIPTION DRUG LABEL	4