FDA.reportPublic FDA data

NDC 72162-2082-02 - 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
72162-2082
Requested NDC
72162-2082-02
Package NDCs from labels
72162-2082-2, 72162-2082-02
Manufacturer
Bryant Ranch Prepack
Effective date
2023-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levalbuterol - Bryant Ranch PrepackBryant Ranch Prepack2023-09-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2082-2Levalbuterol1 in 1 CARTONSOLUTION1100
72162-2082-2Levalbuterol25 in 1 POUCHSOLUTION25100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2082LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230916_d4080fc5-50d6-49a9-8a63-7769d201968d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2082-2ML - Milliliter72162-2082aae6b785-8218-4b0a-8047-d92a641952a612023-10-16

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 19 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
ndc (package): 72162-2082-2
ndc (product): 72162-2082
ndc11 (package): 72162208202
rxcui: 311286
spl id: 308a5c8b-e02d-4660-8dd6-2df0dfd0414b
spl set id: d4080fc5-50d6-49a9-8a63-7769d201968d
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
rxcui: 311286
unii: WDQ1526QJM
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBurel Pharmaceuticals, LLC737fe40b-798b-4d7f-bec9-7af952018ab52021-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA203653
rxcui: 349590
rxcui: 242754
rxcui: 311286
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
ndc (product): 0115-9931
rxcui: 349590
rxcui: 242754
rxcui: 311286
spl id: be1c7c11-31c8-4e84-bf0a-e395f0a21485
spl set id: e5c8368a-49f9-45cf-9d42-a871f005edb9
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.