Levalbuterol Inhalation Solution

Product NDC: 47335-753
11-digit product format: 473350753
Labeler code: 47335
Product ID: 47335-753_f264b091-1414-4e44-abae-d0b787c94397
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levalbuterol Inhalation Solution
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA207820
Marketing category: ANDA
Marketing start: 2018-12-01
Substance: LEVALBUTEROL HYDROCHLORIDE
Active strength: 1.25 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207820-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05
A207820-002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05
A207820-003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A207820-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207820-002	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207820-003	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-003	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207820-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207820-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207820-003	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207820-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207820-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207820-003	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207820-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207820-002	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207820-003	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207820-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207820-002	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207820-003	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207820-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207820-002	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207820-003	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-001	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-002	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-003	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207820-001	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207820-002	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207820-003	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207820-001	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207820-002	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207820-003	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207820-001	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207820-002	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207820-003	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207820-001	AN	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207820-002	AN	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207820-003	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207820-001	AN	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207820-002	AN	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207820-003	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207820-001	AN	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levalbuterol Inhalation Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVALBUTEROL HYDROCHLORIDE	1.25 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WDQ1526QJM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242754	Internal RxNorm lookup
311286	Internal RxNorm lookup
349590	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
85a59e0c-ff09-49a6-b7b8-616e033107b4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b93cc5d-8105-47d8-8ae6-077d0f655880	Product name	3	20190213
415a13b7-458d-4b44-ab20-f56d8ef7ab9d	Product name	2	20170426
a511b237-73ca-80ef-2a42-a935d09028ad	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-753-01	Levalbuterol Inhalation Solution	5 in 1 POUCH	SOLUTION	5	4
47335-753-01	Levalbuterol Inhalation Solution	5 in 1 CARTON	SOLUTION	5	4
47335-753-49	Levalbuterol Inhalation Solution	2 in 1 CARTON	SOLUTION	2	4
47335-753-49	Levalbuterol Inhalation Solution	12 in 1 POUCH	SOLUTION	12	4
47335-753-52	Levalbuterol Inhalation Solution	5 in 1 POUCH	SOLUTION	5	4
47335-753-52	Levalbuterol Inhalation Solution	6 in 1 CARTON	SOLUTION	6	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-753	LEVALBUTEROL INHALATION SOLUTION SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 6 package rows	20200501_85a59e0c-ff09-49a6-b7b8-616e033107b4.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
Levalbuterol Inhalation Solution	LEVALBUTEROL INHALATION SOLUTION	Sun Pharmaceutical Industries, Inc.	85a59e0c-ff09-49a6-b7b8-616e033107b4	2020-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207820 application number: ANDA207820 ndc (product): 47335-753

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WDQ1526QJM	LEVALBUTEROL HYDROCHLORIDE	50293-90-8	LEVALBUTEROL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349590	levalbuterol HCl 0.31 MG in 3 ML Inhalation Solution	PSN	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
311286	levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution	PSN	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
242754	levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution	PSN	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
349590	levalbuterol 0.103 MG/ML Inhalation Solution	SCD	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
311286	levalbuterol 0.21 MG/ML Inhalation Solution	SCD	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
242754	levalbuterol 0.417 MG/ML Inhalation Solution	SCD	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
349590	levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation Solution	SY	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
311286	levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution	SY	85a59e0c-ff09-49a6-b7b8-616e033107b4	4
242754	levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution	SY	85a59e0c-ff09-49a6-b7b8-616e033107b4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-753-01	47335075301	5 POUCH in 1 CARTON (47335-753-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE	5 pouch	2020-07-01	0000-00-00	No	No	Current
47335-753-49	47335075349	2 POUCH in 1 CARTON (47335-753-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE	2 pouch	2018-12-01	0000-00-00	No	No	Current
47335-753-52	47335075352	6 POUCH in 1 CARTON (47335-753-52) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE	6 pouch	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Medicare Limited	2020-04-23	Human Prescription Drug Label	4