BUDESONIDE DELAYED-RELEASE CAPSULES

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-02-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 21:25:47

Label at a glance#

Productbudesonide

Active ingredientBUDESONIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1075-1 in bottle of 100 capsules

Budesonide Delayed-Release Capsules 3 mg

100 capsules

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1244214	budesonide 3 MG Delayed Release Oral Capsule	PSN	8
1244214	budesonide 3 MG Delayed Release Oral Capsule	SCD	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUDESONIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1075-0	budesonide	1000 in 1 BOTTLE	CAPSULE, COATED PELLETS	1000	8
70771-1075-1	budesonide	100 in 1 BOTTLE	CAPSULE, COATED PELLETS	100	8
70771-1075-3	budesonide	30 in 1 BOTTLE	CAPSULE, COATED PELLETS	30	8
70771-1075-4	budesonide	10 in 1 CARTON	CAPSULE, COATED PELLETS	10	8
70771-1075-4	budesonide	10 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	10	8
70771-1075-5	budesonide	500 in 1 BOTTLE	CAPSULE, COATED PELLETS	500	8
70771-1075-9	budesonide	90 in 1 BOTTLE	CAPSULE, COATED PELLETS	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1075	BUDESONIDE CAPSULE, COATED PELLETS [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 7 package rows	20250214_d645a346-c99b-4de7-9bca-69e73266d6b4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

budesonide
ACETYLTRIBUTYL CITRATE
ALCOHOL
AMMONIA
BUTYL ALCOHOL
DIMETHICONE
ETHYLCELLULOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
ISOPROPYL ALCOHOL
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1075	70771-1075-3, 70771-1075-9, 70771-1075-1, 70771-1075-5, 70771-1075-0, 70771-1075-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUDESONIDE	Q3OKS62Q6X	ACTIB
ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	IACT
ALCOHOL	3K9958V90M	IACT
AMMONIA	5138Q19F1X	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
DIMETHICONE	92RU3N3Y1O	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN	2G86QN327L	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	NX76LV5T8J	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206134-001	BUDESONIDE	3MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2017-05-04	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206134-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206134-001	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide	BUDESONIDE	Zydus Lifesciences Limited	d645a346-c99b-4de7-9bca-69e73266d6b4	2025-02-12		Exact identifier ndc (package): 70771-1075-3 ndc (package): 70771-1075-1 ndc (package): 70771-1075-9 ndc (package): 70771-1075-4 ndc (package): 70771-1075-0 ndc (package): 70771-1075-5 ndc (product): 70771-1075 ndc11 (package): 70771107504 ndc11 (package): 70771107509 ndc11 (package): 70771107500 ndc11 (package): 70771107501 ndc11 (package): 70771107505 ndc11 (package): 70771107503 spl id: bfde9c2e-2ff5-4258-91bc-78a48b228d14 spl set id: d645a346-c99b-4de7-9bca-69e73266d6b4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.