Albuterol Sulfate

Product NDC: 64980-643
Requested package NDC: 64980-643-03
11-digit product format: 649800643
Labeler code: 64980
Product ID: 64980-643_56c0a24f-4608-be23-e063-6294a90a9be2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albuterol Sulfate
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Rising Pharma Holdings, Inc
Application: ANDA076355
Marketing category: ANDA
Marketing start: 2025-04-14
Substance: ALBUTEROL SULFATE
Active strength: .63 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A076355-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28
A076355-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076355-001	AN
A076355-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RS	2004-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2004-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2004-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2004-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076355-001	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2004-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076355-002	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2010-03-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A076355-001	AN	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076355-002	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076355-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076355-002	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076355-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076355-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076355-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076355-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076355-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076355-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076355-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076355-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076355-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076355-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076355-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076355-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076355-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076355-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076355-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076355-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076355-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076355-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076355-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076355-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076355-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076355-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076355-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076355-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076355-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076355-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076355-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076355-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076355-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076355-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076355-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076355-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076355-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076355-002	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076355-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076355-002	AN	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Albuterol Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALBUTEROL SULFATE	.63 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
021SEF3731	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351136	Internal RxNorm lookup
351137	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
32474c0e-af35-69d1-e063-6394a90a53c6	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64980-643-03	Albuterol Sulfate	1 in 1 POUCH	SOLUTION	1		2
64980-643-03	Albuterol Sulfate	30 in 1 CARTON	SOLUTION	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-643	ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC]	2	Current NDC, 2 package rows	20250419_32474c0e-af35-69d1-e063-6394a90a53c6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc	32474c0e-af35-69d1-e063-6394a90a53c6	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076355 application number: ANDA076355 ndc (package): 64980-643-03 ndc (product): 64980-643 ndc11 (package): 64980064303
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	285a656c-f77f-4e77-b0a8-a0e9c901803f	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076355 application number: ANDA076355
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076355 application number: ANDA076355

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
351137	albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation Solution	PSN	32474c0e-af35-69d1-e063-6394a90a53c6	2
351136	albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation Solution	PSN	32474c0e-af35-69d1-e063-6394a90a53c6	2
351137	albuterol 0.21 MG/ML Inhalation Solution	SCD	32474c0e-af35-69d1-e063-6394a90a53c6	2
351136	albuterol 0.417 MG/ML Inhalation Solution	SCD	32474c0e-af35-69d1-e063-6394a90a53c6	2
351136	albuterol 0.042 % (1.25 MG/3 ML) Inhalation Solution	SY	32474c0e-af35-69d1-e063-6394a90a53c6	2
351137	albuterol 0.63 MG (albuterol sulfate 0.75 MG) per 3 ML Inhalation Solution	SY	32474c0e-af35-69d1-e063-6394a90a53c6	2
351136	albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation Solution	SY	32474c0e-af35-69d1-e063-6394a90a53c6	2
351137	albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation Solution	SY	32474c0e-af35-69d1-e063-6394a90a53c6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-643-03	64980064303	30 POUCH in 1 CARTON (64980-643-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE	30 pouch	2025-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Inhalation Solution, USP 0.021% * (0.63 mg* / 3 mL) and 0.042%* (1.25 mg* / 3 mL)	Rising Pharma Holdings, Inc \| Nephron SC, LLC	2026-07-16	HUMAN PRESCRIPTION DRUG LABEL	3