Albuterol Sulfate Inhalation Solution

Product NDC: 65302-060
11-digit product format: 653020060
Labeler code: 65302
Product ID: 65302-060_f06cec73-d56c-eb04-e053-2a95a90a4d50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: The Ritedose Corporation
Application: ANDA214531
Marketing category: ANDA
Marketing start: 2022-01-04
Marketing end: 0000-00-00
Substance: ALBUTEROL SULFATE
Active strength: 1 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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
A214531-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28
A214531-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214531-001	AN
A214531-002	AN

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 · 64 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	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A214531-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214531-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214531-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214531-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214531-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214531-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214531-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214531-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214531-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214531-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214531-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214531-002	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214531-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214531-002	AN	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-001	AN	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-002	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214531-001	AN	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214531-002	AN	1	`1c564ffb4f44…`

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
Albuterol Sulfate Inhalation Solution	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	d4c532be-1f41-60d3-e053-2995a90a98be	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214531 application number: ANDA214531
Albuterol	ALBUTEROL	Mylan Pharmaceuticals Inc.	9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6	2026-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214531 application number: ANDA214531

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65302-060-01	65302006001	30 POUCH in 1 CARTON (65302-060-01) > 1 AMPULE in 1 POUCH > 3 mL in 1 AMPULE	30 pouch	2022-01-04	0000-00-00	No	No	Current
65302-060-05	65302006005	25 POUCH in 1 CARTON (65302-060-05) > 5 AMPULE in 1 POUCH > 3 mL in 1 AMPULE	25 pouch	2022-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL	The Ritedose Corporation	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	1