Levalbuterol

Product NDC: 67296-2271
11-digit product format: 672962271
Labeler code: 67296
Product ID: 67296-2271_56cb1edc-0dee-058d-e063-6394a90a98b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levalbuterol Hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Redpharm Drug
Application: ANDA203653
Marketing category: ANDA
Marketing start: 2016-03-22
Substance: LEVALBUTEROL HYDROCHLORIDE
Active strength: .63 mg/3mL
Pharmacologic classes: Adrenergic beta2-Agonists [MoA]; beta2-Adrenergic Agonist [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203653-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22
A203653-002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22
A203653-003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203653-001	AN
A203653-002	AN
A203653-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2016-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2016-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203653-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2016-03-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203653-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203653-002	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203653-003	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-002	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203653-003	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203653-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203653-002	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203653-003	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-002	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203653-003	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203653-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203653-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203653-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203653-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203653-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203653-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203653-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203653-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203653-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203653-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-002	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203653-003	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203653-001	AN	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVALBUTEROL HYDROCHLORIDE	.63 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311286	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
56cb1f4b-ddf4-0661-e063-6394a90a9c45	Available on FDA.report

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Redpharm Drug	56cb1f4b-ddf4-0661-e063-6394a90a9c45	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653 ndc (product): 67296-2271
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Ritedose Pharmaceuticals, LLC	d6998949-e1cb-4c86-a480-c0dfd9cb75b5	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	e7e3d858-6a0d-482c-b71b-de90d3ef3169	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	d4080fc5-50d6-49a9-8a63-7769d201968d	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	A-S Medication Solutions	262c0b8b-8461-4bdf-b272-c829d33fd451	2023-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Burel Pharmaceuticals, LLC	737fe40b-798b-4d7f-bec9-7af952018ab5	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL	Mylan Pharmaceuticals Inc.	5b4fa89e-aa46-4504-a275-246f3b4df1df	2020-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	e5c8368a-49f9-45cf-9d42-a871f005edb9	2019-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203653 application number: ANDA203653

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
67296-2271-2	67296227102	1 POUCH in 1 CARTON (67296-2271-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE	1 pouch	2017-02-17	0	Current