Levalbuterol

Product NDC: 0115-9930
11-digit product format: 001159930
Labeler code: 0115
Product ID: 0115-9930_be1c7c11-31c8-4e84-bf0a-e395f0a21485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levalbuterol Hydrochloride
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA203653
Marketing category: ANDA
Marketing start: 2016-03-22
Substance: LEVALBUTEROL HYDROCHLORIDE
Active strength: .31 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 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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVALBUTEROL HYDROCHLORIDE	.31 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
e5c8368a-49f9-45cf-9d42-a871f005edb9	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-9930-78	2023-02-03	C162847	48780-1	f386c649-c802-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only
0115-9930-78	2023-01-30	C162847	48780-1	f386c649-c802-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0115-9930-76	Levalbuterol	3 mL in 1 AMPULE	SOLUTION	3	5
0115-9930-76	Levalbuterol	25 in 1 POUCH	SOLUTION	25	5
0115-9930-78	Levalbuterol	1 in 1 CARTON	SOLUTION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-9930-76	ML - Milliliter	0115-9930	abbf12b3-1b67-4517-af7c-319d795c9e7e	1	2018-03-08
0115-9930-78	ML - Milliliter	0115-9930	353c02ef-cb49-405d-8652-cfad7f6752fa	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-9930	LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	5	Current NDC, Legacy NDC, 3 package rows	20230204_e5c8368a-49f9-45cf-9d42-a871f005edb9.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 · 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
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 ndc (product): 0115-9930

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	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	100
349590	levalbuterol 0.103 MG/ML Inhalation Solution	SCD	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	100
349590	levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation Solution	SY	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	100
349590	levalbuterol HCl 0.31 MG in 3 ML Inhalation Solution	PSN	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
311286	levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution	PSN	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
242754	levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution	PSN	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
349590	levalbuterol 0.103 MG/ML Inhalation Solution	SCD	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
311286	levalbuterol 0.21 MG/ML Inhalation Solution	SCD	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
242754	levalbuterol 0.417 MG/ML Inhalation Solution	SCD	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
349590	levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation Solution	SY	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
311286	levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution	SY	e5c8368a-49f9-45cf-9d42-a871f005edb9	5
242754	levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution	SY	e5c8368a-49f9-45cf-9d42-a871f005edb9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-9930-76	00115993076	3 mL in 1 AMPULE	3 ml					Historical
0115-9930-78	00115993078	1 POUCH in 1 CARTON (0115-9930-78) / 25 AMPULE in 1 POUCH (0115-9930-76) / 3 mL in 1 AMPULE	1 pouch	2017-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levalbuterol	Bryant Ranch Prepack	2023-09-13	HUMAN PRESCRIPTION DRUG LABEL	100
Levalbuterol	Amneal Pharmaceuticals of New York LLC \| The Ritedose Corporation	2019-06-29	HUMAN PRESCRIPTION DRUG LABEL	5