ProAir RespiClick

Product NDC: 53002-1750
11-digit product format: 530021750
Labeler code: 53002
Product ID: 53002-1750_740a54b2-fc44-48b5-87ba-3073f6a1cf9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA205636
Marketing category: NDA
Marketing start: 2015-04-23
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 90 ug/1
Pharmacologic classes: 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	53002-1750		I	Inactivated by FDA		2026-08-03
excluded package	package	53002-1750	53002-1750-1	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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1750-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1750-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1750-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1750-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1750-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1750-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1750-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1750-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1750-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1750-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1750-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
N205636-001	PROAIR RESPICLICK	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION		RLD, RS	2015-03-31
N205636-002	PROAIR DIGIHALER	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION		RLD	2018-12-21

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,149 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N205636-001	10765820	2025-05-19	Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9463288	2025-05-19	Drug product	2016-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	8651103	2028-03-26	Drug product	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	10022510	2031-05-18	Drug product	2018-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	10124131	2031-05-18	Drug product	2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9731087	2031-05-18	Drug product	2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9216260	2031-06-28	Drug product	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	8978966	2032-01-13	Drug product	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10765820	2025-05-19	Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9463288	2025-05-19	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	8651103	2028-03-26	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10022510	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10124131	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9731087	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9216260	2031-06-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	8978966	2032-01-13	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9782550	2035-08-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9782551	2035-08-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10918816	2035-12-14	Drug product	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10569034	2036-08-16	Drug product	2020-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11351317	2038-02-10	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11357935	2038-09-24	Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11000653	2038-12-18	Drug product	2021-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11344685	2039-09-26	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11439777	2040-05-24	Drug product	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11464923	2040-06-19	Drug product	2022-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11173259	2040-07-06	Drug product	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11266796	2041-02-22	Drug product	2022-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10765820	2025-05-19	Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9463288	2025-05-19	Drug product	2016-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	8651103	2028-03-26	Drug product	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10022510	2031-05-18	Drug product	2018-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10124131	2031-05-18	Drug product	2018-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9731087	2031-05-18	Drug product	2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9216260	2031-06-28	Drug product	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10561808	2032-01-01	Drug product	2020-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	8978966	2032-01-13	Drug product	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	10765820	2025-05-19	Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	9463288	2025-05-19	Drug product	2019-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	8651103	2028-03-26	Drug product	2019-01-09	`fd3edfee7708…`

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	N205636-001	NPP	2019-04-28	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205636-001	NPP	2019-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205636-001	NPP	2019-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205636-001	NPP	2019-04-28	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
2023-06-07	These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
2023-01-30	These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
2020-12-15	These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981
2020-01-31	These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See full prescribing information for PROAIR RESPICLICK. PROAIR® RESPICLICK® (albuterol sulfate) inhalation powder, for oral inhalation use Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1750-1	ProAir RespiClick	1 in 1 BOX	POWDER, METERED	1		5
53002-1750-1	ProAir RespiClick	200 in 1 INHALER	POWDER, METERED	200		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1750	PROAIR RESPICLICK (ALBUTEROL SULFATE) POWDER, METERED [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_28e6becd-a65a-4245-b282-5766127567a2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProAir RespiClick	ALBUTEROL SULFATE	Teva Respiratory, LLC	9324e2eb-26fd-4f14-9f10-e5aa467306f4	2022-09-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205636 application number: NDA205636
ProAir Digihaler	ALBUTEROL SULFATE	Teva Respiratory, LLC	667ce3ec-5217-4b10-b712-f3e54fbbf087	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205636 application number: NDA205636

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649560	albuterol sulfate 90 MCG/INHAL Dry Powder Inhaler, 200 Actuations	PSN	28e6becd-a65a-4245-b282-5766127567a2	5
1649961	ProAir RespiClick 90 MCG/INHAL Dry Powder Inhaler, 200 Actuations	PSN	28e6becd-a65a-4245-b282-5766127567a2	5
1649961	200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler [ProAir]	SBD	28e6becd-a65a-4245-b282-5766127567a2	5
1649560	200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler	SCD	28e6becd-a65a-4245-b282-5766127567a2	5
1649961	200 ACTUAT ProAir 0.09 MG/ACTUAT Dry Powder Inhaler	SY	28e6becd-a65a-4245-b282-5766127567a2	5
1649560	albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 200 ACTUAT Dry Powder Inhaler	SY	28e6becd-a65a-4245-b282-5766127567a2	5
1649560	albuterol 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUAT	SY	28e6becd-a65a-4245-b282-5766127567a2	5
1649961	ProAir RespiClick 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Dry Powder Inhaler, 200 ACTUAT	SY	28e6becd-a65a-4245-b282-5766127567a2	5
1649961	ProAir RespiClick 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUAT	SY	28e6becd-a65a-4245-b282-5766127567a2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1750-1	53002175001	1 INHALER in 1 BOX (53002-1750-1) > 200 POWDER, METERED in 1 INHALER	1 inhaler	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ProAir RespiClick - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5