levalbuterol inhalation

Product NDC: 43598-409
11-digit product format: 435980409
Labeler code: 43598
Product ID: 43598-409_3ec07be3-1e04-66a2-ffee-b4795006fae9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levalbuterol inhalation 1.25mg/3mL
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Dr. Reddy
Application: ANDA078171
Marketing category: ANDA
Marketing start: 2014-09-16
Marketing end: 0000-00-00
Substance: LEVALBUTEROL
Active strength: 1 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	43598-409		D	Discontinued by firm		2026-10-12
excluded package	package	43598-409	43598-409-25	D	Discontinued by firm		2026-10-12

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	TE codes	Approval date
A078171-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13
A078171-002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13
A078171-003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078171-001	AN
A078171-002	AN
A078171-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078171-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078171-002	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078171-003	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078171-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078171-002	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078171-003	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078171-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078171-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078171-003	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078171-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078171-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078171-003	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078171-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078171-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078171-003	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078171-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078171-002	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078171-003	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078171-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078171-002	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078171-003	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078171-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078171-002	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078171-003	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078171-001	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078171-002	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078171-003	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078171-001	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078171-002	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078171-003	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078171-001	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078171-002	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078171-003	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078171-001	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078171-002	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078171-003	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078171-001	AN	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078171-002	AN	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-409-25	ML - Milliliter	43598-409	c9bd88c9-ec5b-4c10-abe2-507c7bd4c302	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Levalbuterol	ACTIVE INGREDIENT	EDN2NBH5SS	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Levalbuterol	ACTIVE MOIETY	EDN2NBH5SS	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Nitrogen	INACTIVE INGREDIENT	N762921K75	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-409	LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDYS LABORATORIES, INC.]	4	Legacy NDC	20241222_163dfa7c-aad3-4290-9fe9-d9592b0ba317.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EDN2NBH5SS	LEVALBUTEROL	34391-04-3	LEVALBUTEROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-409-25	43598040925	5 POUCH in 1 CARTON (43598-409-25) > 5 VIAL in 1 POUCH (43598-409-05) > 3 mL in 1 VIAL	5 pouch	2014-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levalbuterol inhalation	Dr. Reddy’s Laboratories, Inc. \| Cipla Limited- Indore \| Cipla Patalganga	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4