Budesonide and Formoterol Fumarate Dihydrate

Product NDC: 53002-2667
11-digit product format: 530022667
Labeler code: 53002
Product ID: 53002-2667_ed2f9421-5a02-4d2b-b1c0-6c1f4f03ed32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide and Formoterol Fumarate Dihydrate
Dosage form: AEROSOL
Route: RESPIRATORY (INHALATION)
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA021929
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-01-03
Marketing end: 0000-00-00
Substance: BUDESONIDE; FORMOTEROL FUMARATE
Active strength: 160 ug/1; ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-2667		I	Inactivated by FDA		2026-08-03
excluded package	package	53002-2667	53002-2667-1	I	Inactivated by FDA		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 · 30 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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`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	53002-2667-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53002-2667-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53002-2667-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53002-2667-1	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021929-001	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21
N021929-002	SYMBICORT	BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021929-001	AB
N021929-002	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 3 · 82 observed 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	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2006-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021929-001	SYMBICORT	0.08MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021929-002	SYMBICORT	0.16MG/INH;0.0045MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2006-07-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	N021929-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021929-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021929-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021929-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021929-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021929-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021929-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021929-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021929-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021929-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021929-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021929-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021929-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021929-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021929-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021929-002	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021929-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021929-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021929-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021929-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021929-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021929-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021929-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021929-002	AB	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 41 · 1,620 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	7587988	2026-04-10	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8387615	2027-03-26	Drug product	2013-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8387615*PED	2027-09-26	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8528545	2028-10-16	Drug product	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8616196	2029-04-07	Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8528545*PED	2029-04-16	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-001	8616196*PED	2029-10-07	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8875699*PED	2025-05-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	7587988	2026-04-10	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	7587988*PED	2026-10-10	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8387615	2027-03-26	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8387615*PED	2027-09-26	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8528545	2028-10-16	Drug product	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8616196	2029-04-07	Drug product	2014-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8528545*PED	2029-04-16	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021929-002	8616196*PED	2029-10-07	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	7587988	2026-04-10	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8387615	2027-03-26	Drug product	2013-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8387615*PED	2027-09-26	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8528545	2028-10-16	Drug product	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8616196	2029-04-07	Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8528545*PED	2029-04-16	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-001	8616196*PED	2029-10-07	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8875699*PED	2025-05-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	7587988	2026-04-10	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	7587988*PED	2026-10-10	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8387615	2027-03-26	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8387615*PED	2027-09-26	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8528545	2028-10-16	Drug product	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8616196	2029-04-07	Drug product	2014-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8528545*PED	2029-04-16	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021929-002	8616196*PED	2029-10-07	Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	8875699	2024-11-10	Drug product	2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	8875699*PED	2025-05-10	Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	7587988	2026-04-10	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021929-001	7587988*PED	2026-10-10	Pediatric extension		`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021929-001	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	M-210	2020-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-001	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	M-210	2020-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021929-002	M-214	2020-12-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021929-001	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	M-210	2020-09-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-001	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-002	M-210	2020-09-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021929-002	M-214	2020-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021929-001	NPP	2020-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	PED	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	M-210	2020-09-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-001	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-002	M-210	2020-09-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021929-002	M-214	2020-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021929-001	NPP	2020-01-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	PED	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	M-210	2020-09-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-001	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-002	M-210	2020-09-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021929-002	M-214	2020-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021929-001	NPP	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	PED	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	M-210	2020-09-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-001	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-002	M-210	2020-09-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021929-002	M-214	2020-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021929-001	NPP	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	PED	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	M-210	2020-09-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-001	M-214	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-002	M-210	2020-09-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021929-002	M-214	2020-12-20	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367	Product name	4	20250303
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
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
58f15a44-d9d2-4d61-a39d-7f0223302a8f	Product name	1	20190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-2667-1	2023-01-30	C162847	48780-1	f386c64a-061a-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2667-1	Budesonide and Formoterol Fumarate Dihydrate	1 in 1 CARTON	AEROSOL	1		1
53002-2667-1	Budesonide and Formoterol Fumarate Dihydrate	1 in 1 POUCH	AEROSOL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2667	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20201222_ca94e217-1828-4a7f-b7c3-3352f00a97d3.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	Sportpharm LLC	d6cc66c9-6f97-4ea8-a787-30a048004c77	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	Sportpharm LLC	a645756c-c692-4bc6-a858-7e7e249561bd	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	6b78d08a-e098-4188-8f7f-94fbd5f396ef	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	b974bab9-c6d2-41ad-b930-28f2904c5f9d	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	805764a1-65e1-4117-ac4a-7a54c3986cfe	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	5feb8f35-b237-477a-9836-2a6db2ed6fa7	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	52f45e18-463e-4ce3-8ccd-c0260473e6b5	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	A-S Medication Solutions	0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
SYMBICORT	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	AstraZeneca Pharmaceuticals LP	fafa4cf1-99c2-43d5-73ad-51f256de3be0	2019-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929
Budesonide and Formoterol Fumarate Dihydrate	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	AstraZeneca Pharmaceuticals LP	1d266fe8-52e3-4f85-a037-c5c1afa15e60	2019-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021929 application number: NDA021929

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246304	budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	ca94e217-1828-4a7f-b7c3-3352f00a97d3	1
1246304	120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler	SCD	ca94e217-1828-4a7f-b7c3-3352f00a97d3	1
1246304	budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	ca94e217-1828-4a7f-b7c3-3352f00a97d3	1
1246304	budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	ca94e217-1828-4a7f-b7c3-3352f00a97d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2667-1	53002266701	1 POUCH in 1 CARTON (53002-2667-1) > 1 AEROSOL in 1 POUCH	1 pouch	2020-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Budesonide and Formoterol Fumarate Dihydrate - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2020-12-21	HUMAN PRESCRIPTION DRUG LABEL	1