FDA.reportPublic FDA data

NDC 0409-0125-01 - Labetalol Hydrochloride

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
0409-0125
Requested NDC
0409-0125-01
Package NDCs from labels
0409-0125-01, 0409-0125-25
Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-09-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LABETALOL - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-09-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0125-01Labetalol Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2028
0409-0125-25Labetalol Hydrochloride25 in 1 TRAYINJECTION, SOLUTION2528

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0125LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]25Current NDC, 2 package rows20241210_abfc6b75-1ed5-41f1-0484-4597488237bc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0125-01ML - Milliliter0409-01253c39fa22-c2da-4058-8d0f-dd0f853a5da412023-09-05
0409-0125-25ML - Milliliter0409-012598c0b555-eb7f-448e-ba91-1fae008bdadd12023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13

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 2 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLCd3ca153c-25b2-4506-91bd-bf9d6a4c01fe2026-05-19Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackc0c1a162-cd30-4ac9-bc62-407493ed54a52026-05-11Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LP54b75509-824b-4291-818d-71dc1b88915f2026-05-01Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGolden State Medical Supply, Inc.d5ce687f-4a37-d3e6-e053-2995a90aa9742026-04-16Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions371cb135-6a5f-433d-a87d-ab8521c4aa6d2026-04-16Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsf9af85d3-a5a7-49d6-aff6-1ca2b2d754502026-04-16Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthStar Rx LLC5bd81a8a-a480-4c8d-bd4f-3158412e6a732026-04-13Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEREMEDYREPACK INC.ae5d7b3b-e444-48d3-9d85-9b07319f93742026-04-10Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAdvagen Pharma Ltd106a0959-5830-489f-ba60-afd4eb0fac362026-04-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAdvagen Pharma Ltd1c680447-b43a-4ff1-bc64-2c2174ca1c9a2026-04-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd4364caf-46c6-4144-9ba5-2c561e4f3a952026-03-26Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd207396a-068e-4229-88cc-a1a4df7aeff22026-03-07Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsb4a5f170-a400-4986-8c64-f55d0413f0f62026-03-07Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.bf84ebae-3c91-4448-b1db-8e5ed30538662026-03-05Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMajor Pharmaceuticals35b5fd32-581d-427b-9a13-b7a02846d21d2026-03-03Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECivica, Inc.d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef82026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5942a5a8-c3c1-4ecb-921e-9bc92393bdf82026-03-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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