BUDESONIDE

Product NDC: 45802-627
11-digit product format: 458020627
Labeler code: 45802
Product ID: 45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: budesonide
Dosage form: AEROSOL, FOAM
Route: RECTAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA215328
Marketing category: ANDA
Marketing start: 2023-04-17
Substance: BUDESONIDE
Active strength: 2 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
A215328-001	BUDESONIDE	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215328-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB		2023-04-12	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215328-001	BUDESONIDE	2MG/ACTUATION	AEROSOL, FOAM / RECTAL	AB	RS	2023-04-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215328-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215328-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215328-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215328-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215328-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215328-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215328-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215328-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215328-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215328-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215328-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215328-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215328-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215328-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215328-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215328-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215328-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215328-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215328-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215328-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215328-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215328-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215328-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A215328-001	CGT	2023-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215328-001	CGT	2023-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215328-001	CGT	2023-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215328-001	CGT	2023-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215328-001	CGT	2023-10-24	`3f0d92c62455…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	2 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
1596779	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
ad4a68e7-9200-4f05-8058-714d5d8900f8	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	Strength	SPL version
45802-627-01	BUDESONIDE	1 in 1 CANISTER	AEROSOL, FOAM	1		1
45802-627-86	BUDESONIDE	2 in 1 CARTON	AEROSOL, FOAM	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-627-01	GM - Gram	45802-627	3ef56ac0-519e-43ad-99c1-95fcfc242621	1	2023-05-05
45802-627-86	GM - Gram	45802-627	549bb7d9-5f26-4c22-9199-11f3d41d1739	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-627	BUDESONIDE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	1	Current NDC, 2 package rows	20230418_ad4a68e7-9200-4f05-8058-714d5d8900f8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUDESONIDE	BUDESONIDE	Padagis Israel Pharmaceuticals Ltd	ad4a68e7-9200-4f05-8058-714d5d8900f8	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215328 application number: ANDA215328 ndc (product): 45802-627

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
1596779	budesonide 2 MG/ACTUAT Rectal Foam, 14 ACTUAT	PSN	ad4a68e7-9200-4f05-8058-714d5d8900f8	1
1596779	14 ACTUAT budesonide 2 MG/ACTUAT Rectal Foam	SCD	ad4a68e7-9200-4f05-8058-714d5d8900f8	1
1596779	budesonide 2 MG/ACTUAT Rectal Foam, 14 ACTUAT	SY	ad4a68e7-9200-4f05-8058-714d5d8900f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
45802-627-01	45802062701	1 in 1 CANISTER					Historical
45802-627-86	45802062786	2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01)	2 canister	2023-04-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUDESONIDE - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	1