Budesonide

Product NDC: 0378-7155
11-digit product format: 003787155
Labeler code: 0378
Product ID: 0378-7155_7c36dbe2-e957-4045-b7a5-7321a7af50b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090410
Marketing category: ANDA
Marketing start: 2011-05-16
Marketing end: 2022-08-31
Substance: BUDESONIDE
Active strength: 3 mg/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0378-7155		D	Discontinued by firm		2026-08-03
excluded package	package	0378-7155	0378-7155-01	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-7155-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-7155-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-7155-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-7155-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-7155-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-7155-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-7155-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-7155-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-7155-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-7155-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-7155-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-7155-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090410-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2011-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090410-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090410-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2011-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090410-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2011-05-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090410-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090410-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090410-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090410-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090410-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090410-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090410-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090410-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090410-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090410-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090410-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090410-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090410-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090410-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090410-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090410-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090410-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090410-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090410-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090410-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090410-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090410-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090410-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090410-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090410-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090410-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090410-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090410-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090410-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090410-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090410-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090410-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090410-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090410-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090410-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090410-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090410-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090410-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090410-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090410-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-7155-01	EA - Each	0378-7155	4f6e5f1c-0fab-44ed-bc20-0b33d4275987	1	2012-07-24
0378-7155-05	EA - Each	0378-7155	83afd047-ea72-4088-b4fb-d816ee8ec1f8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUDESONIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	3
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUDESONIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
BUDESONIDE	ACTIVE INGREDIENT	Q3OKS62Q6X	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
BUDESONIDE	ACTIVE MOIETY	Q3OKS62Q6X	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUDESONIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

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
1244214	budesonide 3 MG Delayed Release Oral Capsule	PSN	7633c9b3-dfb5-446f-a260-e44b6e48afa2	2
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	7633c9b3-dfb5-446f-a260-e44b6e48afa2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-7155-01	00378715501	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7155-01)	100 capsule	2011-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	Golden State Medical Supply, Inc.	2022-04-12	HUMAN PRESCRIPTION DRUG LABEL	6
Budesonide	Mylan Pharmaceuticals Inc.	2020-11-19	HUMAN PRESCRIPTION DRUG LABEL	10
Budesonide	Carilion Materials Management	2014-03-05	HUMAN PRESCRIPTION DRUG LABEL	2