NDC 76204-800-15 - 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
76204-800
Requested NDC
76204-800-15
Package NDCs from labels
76204-800-11, 76204-800-01, 76204-800-05, 76204-800-55, 76204-800-15, 76204-800-25
Manufacturer
Redpharm Drug
Effective date
2026-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levalbuterol - Redpharm DrugRedpharm Drug2026-07-17HUMAN PRESCRIPTION DRUG LABEL
Levalbuterol - Ritedose Pharmaceuticals, LLC | The Ritedose CorporationRitedose Pharmaceuticals, LLC | The Ritedose Corporation2025-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-800-01Levalbuterol30 in 1 CARTONSOLUTION3022
76204-800-05Levalbuterol5 in 1 POUCHSOLUTION522
76204-800-05Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-800-11Levalbuterol1 in 1 POUCHSOLUTION122
76204-800-11Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-800-15Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-800-15Levalbuterol25 in 1 POUCHSOLUTION2522
76204-800-25Levalbuterol1 in 1 CARTONSOLUTION122
76204-800-55Levalbuterol5 in 1 CARTONSOLUTION522

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-800LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]20Current NDC, Legacy NDC, 9 package rows20241219_d6998949-e1cb-4c86-a480-c0dfd9cb75b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-800-01ML - Milliliter76204-800e0725bdf-61e5-4b1d-a17a-52f53350b53112017-07-07
76204-800-11ML - Milliliter76204-800e3158432-5144-4025-8892-4896b863c68212017-07-07
76204-800-12ML - Milliliter76204-800b3ea1140-ada1-435f-90ba-1bda1fbccf7c12016-05-16
76204-800-15ML - Milliliter76204-800c8236cc1-42fa-44c6-95db-33d3811eac3512017-08-11
76204-800-24ML - Milliliter76204-800078d1508-6ce2-455e-9c40-21bc9b281ff912016-05-16
76204-800-25ML - Milliliter76204-80017863b76-8f05-4dcd-a1f9-eba183a3650612017-08-11

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
ndc (package): 67296-2271-2
ndc (product): 67296-2271
rxcui: 311286
spl id: 56cb1edc-0dee-058d-e063-6394a90a98b8
spl set id: 56cb1f4b-ddf4-0661-e063-6394a90a9c45
unii: WDQ1526QJM
LevalbuterolLEVALBUTEROL HYDROCHLORIDERitedose Pharmaceuticals, LLCd6998949-e1cb-4c86-a480-c0dfd9cb75b52025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA203653
ndc (package): 76204-800-55
ndc (package): 76204-900-11
ndc (package): 76204-700-55
ndc (package): 76204-700-25
ndc (package): 76204-700-01
ndc (package): 76204-700-11
ndc (package): 76204-700-05
ndc (package): 76204-900-55
ndc (package): 76204-900-25
ndc (package): 76204-800-25
ndc (package): 76204-800-15
ndc (package): 76204-800-01
ndc (package): 76204-900-05
ndc (package): 76204-800-11
ndc (package): 76204-700-15
ndc (package): 76204-900-01
ndc (package): 76204-800-05
ndc (package): 76204-900-15
ndc (product): 76204-700
ndc (product): 76204-800
ndc (product): 76204-900
ndc11 (package): 76204080015
rxcui: 349590
rxcui: 242754
rxcui: 311286
spl id: 459fa0f5-35d9-d6e5-e063-6394a90a6f14
spl set id: d6998949-e1cb-4c86-a480-c0dfd9cb75b5
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
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
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.