FDA.reportPublic FDA data

NDC 50090-6377-00 - 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
50090-6377
Requested NDC
50090-6377-00
Package NDCs from labels
50090-6377-0, 50090-6377-00
Manufacturer
A-S Medication Solutions
Effective date
2023-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levalbuterol - A-S Medication SolutionsA-S Medication Solutions2023-02-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6377-0Levalbuterol1 in 1 CARTONSOLUTION12
50090-6377-0Levalbuterol25 mL in 1 POUCHSOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6377LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20230301_262c0b8b-8461-4bdf-b272-c829d33fd451.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6377-0ML - Milliliter50090-637741f46794-e2a2-4a1a-9742-5daaa33825d812023-04-07

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 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevalbuterolLEVALBUTEROL HYDROCHLORIDERedpharm Drug58beb877-b94a-bbe0-e063-6294a90a7fe02026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDERedpharm Drug56cb1f4b-ddf4-0661-e063-6394a90a9c452026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDERitedose Pharmaceuticals, LLCd6998949-e1cb-4c86-a480-c0dfd9cb75b52025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLLuoxin Aurovitas Pharma (Chengdu) Co., Ltd.29eae75d-93da-7a5a-e063-6394a90ac0c02024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLAurobindo Pharma Limited5f1c4f22-d420-495c-8f64-33532638215f2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LEVALBUTEROLLEVALBUTEROLAurobindo Pharma Limitede1a9effb-6ef7-4651-b0ef-a9265600caff2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepacke7e3d858-6a0d-482c-b71b-de90d3ef31692023-09-14Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 242754
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepackd4080fc5-50d6-49a9-8a63-7769d201968d2023-09-14Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBryant Ranch Prepack2f416dc8-62aa-4b6b-a745-2c8a72bb763d2023-09-13Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 349590
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEA-S Medication Solutions262c0b8b-8461-4bdf-b272-c829d33fd4512023-02-28Warnings, Adverse reactionsExact identifier
application number: ANDA203653
ndc (package): 50090-6377-0
ndc (product): 50090-6377
ndc11 (package): 50090637700
rxcui: 311286
spl id: 9c6c8e7b-61bd-437b-ba6e-cb394ad19d16
spl set id: 262c0b8b-8461-4bdf-b272-c829d33fd451
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBurel Pharmaceuticals, LLC737fe40b-798b-4d7f-bec9-7af952018ab52021-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA203653
ndc (product): 35573-444
rxcui: 349590
rxcui: 242754
rxcui: 311286
spl id: 0639bb69-d41d-4786-af70-797c452fbbfb
spl set id: 737fe40b-798b-4d7f-bec9-7af952018ab5
unii: WDQ1526QJM
Levalbuterol Inhalation SolutionLEVALBUTEROL INHALATION SOLUTIONSun Pharmaceutical Industries, Inc.85a59e0c-ff09-49a6-b7b8-616e033107b42020-04-23Warnings, Adverse reactionsExact identifier
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLMylan Pharmaceuticals Inc.5b4fa89e-aa46-4504-a275-246f3b4df1df2020-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLMylan Pharmaceuticals Inc.206bbdec-04f0-40e3-a259-32fc6bce20d82019-11-11Warnings, Adverse reactionsExact identifier
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLProficient Rx LP97699821-81f8-4623-8504-e479c0f4b1832019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe5c8368a-49f9-45cf-9d42-a871f005edb92019-06-29Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 349590
rxcui: 242754
rxcui: 311286
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROLTeva Pharmaceuticals USA, Inc.f3ce78d9-e923-400e-b3cd-3e6124ac7f6d2019-01-31Warnings, Adverse reactionsExact 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.