NDC 0172-4365-10 - 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
0172-4365
Requested NDC
0172-4365-10
Package NDCs from labels
0172-4365-10
Manufacturer
Dispensing Solutions, Inc. | PSS World Medical, Inc.
Effective date
2013-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LABETALOL HYDROCHLORIDE TABLETS USP Rx onlyDispensing Solutions, Inc. | PSS World Medical, Inc.2013-11-07HUMAN PRESCRIPTION DRUG LABEL
Labetalol Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-04-02HUMAN PRESCRIPTION DRUG LABEL
Labetalol Hydrochloride - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2012-03-29HUMAN PRESCRIPTION DRUG LABEL
Labetalol Hydrochloride - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2011-08-29HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-4365-00EA - Each0172-43652bc658b4-6758-4fa5-a2f0-5c8e02c68f0d12012-07-24
0172-4365-10EA - Each0172-43650b67f826-87b7-415c-992b-e1a2ae89b28712012-07-24
0172-4365-60EA - Each0172-43658ba64440-54e8-4ee5-83eb-d735d123e41b12012-07-24
0172-4365-70EA - Each0172-436558785296-3828-4bc3-88dc-99056276c5cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J0LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
Labetalol HydrochlorideACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1

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 112 · 2,238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC63db5b00-e864-4b2d-84f2-00bf35211b9b2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 896758
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECoupler LLC5954cc5c-3e73-e039-e063-6394a90a7d6a2026-08-18Warnings, Adverse reactionsExact identifier
application number: ANDA074787
rxcui: 896758
unii: 1GEV3BAW9J
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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