FDA.reportPublic FDA data

NDC 49884-122-10 - Labetalol HCL

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
49884-122
Requested NDC
49884-122-10
Package NDCs from labels
49884-122-01, 49884-122-05, 49884-122-10
Manufacturer
A-S Medication Solutions
Effective date
2025-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol HCL - A-S Medication SolutionsA-S Medication Solutions2025-06-19HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - Bryant Ranch PrepackBryant Ranch Prepack2024-10-04HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - Par Health USA, LLCPar Health USA, LLC2024-09-24HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx onlyREMEDYREPACK INC.2024-01-26HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - Bryant Ranch PrepackBryant Ranch Prepack2023-08-11HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - Bryant Ranch PrepackBryant Ranch Prepack2023-08-11HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2023-01-09HUMAN PRESCRIPTION DRUG LABEL
Labetalol HCL - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2021-08-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-122LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [ENDO USA, INC.]16Legacy NDC20240926_56ab2ff4-14a6-4297-afd8-56b92e1f64a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-122-01EA - Each49884-122bd4cebdf-7111-4219-9610-e9b1875d146d12013-02-13
49884-122-05EA - Each49884-1223cef117a-22bb-477a-8a6d-33eac87bbe2f12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1ULABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]9

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 144 · 2,864 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC63db5b00-e864-4b2d-84f2-00bf35211b9b2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 896758
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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