NDC 0115-9930-76 - Levalbuterol

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0115-9930
Requested NDC: 0115-9930-76
Package NDCs from labels: 0115-9930-76, 0115-9930-78
Manufacturer: Bryant Ranch Prepack
Effective date: 2023-09-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

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

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 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

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

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Redpharm Drug	58beb877-b94a-bbe0-e063-6294a90a7fe0	2026-08-11	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Redpharm Drug	56cb1f4b-ddf4-0661-e063-6394a90a9c45	2026-07-17	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Ritedose Pharmaceuticals, LLC	d6998949-e1cb-4c86-a480-c0dfd9cb75b5	2025-12-10	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	29eae75d-93da-7a5a-e063-6394a90ac0c0	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Aurobindo Pharma Limited	5f1c4f22-d420-495c-8f64-33532638215f	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
LEVALBUTEROL	LEVALBUTEROL	Aurobindo Pharma Limited	e1a9effb-6ef7-4651-b0ef-a9265600caff	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	e7e3d858-6a0d-482c-b71b-de90d3ef3169	2023-09-14	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 242754 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	d4080fc5-50d6-49a9-8a63-7769d201968d	2023-09-14	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	2023-09-13	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 ndc (package): 72162-2081-2 ndc (product): 72162-2081 rxcui: 349590 spl id: 005d9f18-702c-4193-bd95-274bee7236b9 spl set id: 2f416dc8-62aa-4b6b-a745-2c8a72bb763d unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	A-S Medication Solutions	262c0b8b-8461-4bdf-b272-c829d33fd451	2023-02-28	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 311286 unii: WDQ1526QJM
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: 7FLD91C86K
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Burel Pharmaceuticals, LLC	737fe40b-798b-4d7f-bec9-7af952018ab5	2021-07-01	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol Inhalation Solution	LEVALBUTEROL INHALATION SOLUTION	Sun Pharmaceutical Industries, Inc.	85a59e0c-ff09-49a6-b7b8-616e033107b4	2020-04-23	Warnings, Adverse reactions	Exact identifier rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Mylan Pharmaceuticals Inc.	5b4fa89e-aa46-4504-a275-246f3b4df1df	2020-02-17	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Mylan Pharmaceuticals Inc.	206bbdec-04f0-40e3-a259-32fc6bce20d8	2019-11-11	Warnings, Adverse reactions	Exact identifier unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Proficient Rx LP	97699821-81f8-4623-8504-e479c0f4b183	2019-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 311286 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	e5c8368a-49f9-45cf-9d42-a871f005edb9	2019-06-29	Warnings, Adverse reactions	Exact identifier application number: ANDA203653 ndc (package): 0115-9931-76 ndc (package): 0115-9930-78 ndc (package): 0115-9931-78 ndc (package): 0115-9930-76 ndc (package): 0115-9932-78 ndc (package): 0115-9932-76 ndc (product): 0115-9932 ndc (product): 0115-9930 ndc (product): 0115-9931 ndc11 (package): 00115993076 rxcui: 349590 rxcui: 242754 rxcui: 311286 spl id: be1c7c11-31c8-4e84-bf0a-e395f0a21485 spl set id: e5c8368a-49f9-45cf-9d42-a871f005edb9 unii: WDQ1526QJM
Levalbuterol	LEVALBUTEROL	Teva Pharmaceuticals USA, Inc.	f3ce78d9-e923-400e-b3cd-3e6124ac7f6d	2019-01-31	Warnings, Adverse reactions	Exact identifier rxcui: 349590 rxcui: 242754 rxcui: 311286 unii: WDQ1526QJM

Reported adverse events (FAERS/openFDA)#

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