budesonide

Product NDC: 68382-720
11-digit product format: 683820720
Labeler code: 68382
Product ID: 68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206134
Marketing category: ANDA
Marketing start: 2017-06-08
Substance: BUDESONIDE
Active strength: 3 mg/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
A206134-001	BUDESONIDE	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2017-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206134-001	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	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206134-001	BUDESONIDE	3MG	CAPSULE / ORAL	AB	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`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	A206134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206134-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206134-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206134-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206134-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206134-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206134-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206134-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206134-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206134-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206134-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	3 mg/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
1244214	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
29863154-5f98-410e-9bf3-0f08b551edef	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	SPL version
68382-720-01	budesonide	100 in 1 BOTTLE	CAPSULE, COATED PELLETS	100	10
68382-720-05	budesonide	500 in 1 BOTTLE	CAPSULE, COATED PELLETS	500	10
68382-720-06	budesonide	30 in 1 BOTTLE	CAPSULE, COATED PELLETS	30	10
68382-720-10	budesonide	1000 in 1 BOTTLE	CAPSULE, COATED PELLETS	1000	10
68382-720-16	budesonide	90 in 1 BOTTLE	CAPSULE, COATED PELLETS	90	10
68382-720-30	budesonide	10 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	10	10
68382-720-77	budesonide	10 in 1 CARTON	CAPSULE, COATED PELLETS	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-720-01	EA - Each	68382-720	cf596e2e-722f-45a4-a47c-7f092dd58961	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-720	BUDESONIDE CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 7 package rows	20250214_29863154-5f98-410e-9bf3-0f08b551edef.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide	BUDESONIDE	REMEDYREPACK INC.	5e39c491-2793-410e-b77f-8b3cbe9b6231	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
Budesonide	BUDESONIDE	American Health Packaging	4a8e79df-3946-4e9a-b214-e9fdd824b565	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
budesonide	BUDESONIDE	Major Pharmaceuticals	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
budesonide	BUDESONIDE	Northstar Rx LLC.	a37866df-df07-4f71-8591-98c2804c4794	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134
budesonide	BUDESONIDE	Zydus Pharmaceuticals USA Inc.	29863154-5f98-410e-9bf3-0f08b551edef	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206134 application number: ANDA206134 ndc (product): 68382-720
budesonide	BUDESONIDE	Zydus Lifesciences Limited	d645a346-c99b-4de7-9bca-69e73266d6b4	2025-02-12		Exact identifier application applno (ANDA): 206134 application number: ANDA206134

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	29863154-5f98-410e-9bf3-0f08b551edef	10
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	29863154-5f98-410e-9bf3-0f08b551edef	10
1244214	budesonide 3 MG Delayed Release Oral Capsule	PSN	4a8e79df-3946-4e9a-b214-e9fdd824b565	4
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	4a8e79df-3946-4e9a-b214-e9fdd824b565	4
1244214	budesonide 3 MG Delayed Release Oral Capsule	PSN	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	e7aca8d1-159e-4aac-b92d-3a69a8edceec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-720-01	68382072001	100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01)		2017-06-08	0000-00-00	No	No	Current
68382-720-05	68382072005	500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05)		2017-06-08	0000-00-00	No	No	Current
68382-720-06	68382072006	30 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06)		2017-06-08	0000-00-00	No	No	Current
68382-720-10	68382072010	1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10)		2017-06-08	0000-00-00	No	No	Current
68382-720-16	68382072016	90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16)		2017-06-08	0000-00-00	No	No	Current
68382-720-30	68382072030	10 in 1 BLISTER PACK						Historical
68382-720-77	68382072077	10 BLISTER PACK in 1 CARTON (68382-720-77) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)	10 blister pack	2017-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide	American Health Packaging	2026-03-09	HUMAN PRESCRIPTION DRUG LABEL	4
budesonide	Major Pharmaceuticals	2025-03-10	HUMAN PRESCRIPTION DRUG LABEL	2
budesonide	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	10