FDA.reportPublic FDA data

NDC 51079-812-01 - Nadolol

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
51079-812
Requested NDC
51079-812-01
Package NDCs from labels
51079-812-01, 51079-812-20
Manufacturer
Mylan Institutional Inc.
Effective date
2021-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nadolol - Mylan Institutional Inc.Mylan Institutional Inc.2021-12-16HUMAN 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
51079-812-01EA - Each51079-812cc797a32-dd5b-490b-b49d-89c91bba689612012-07-24
51079-812-20EA - Each51079-8122e94e49d-b2a6-4b51-a906-8bdf99cfc18412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NADOLOLACTIVE INGREDIENTFEN504330VNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
NADOLOLACTIVE MOIETYFEN504330VNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNADOLOL TABLET [MYLAN INSTITUTIONAL INC.]2

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NadololNADOLOLBluePoint Laboratoriesf11553f1-18ec-41b0-a7ad-1c9f21ef2c9f2026-09-07Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLAmerican Health Packaging9acc0c81-4145-43cc-b31a-7b1e3313259d2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLA-S Medication Solutions4580b85b-437c-4c52-bf31-5976968ecd5c2026-06-19Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLBryant Ranch Prepackc154d99c-e4fb-41d0-8fac-e1982672e8d72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLREMEDYREPACK INC.8a224f90-24a5-411e-ac26-6496a1930f3a2026-05-18Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLAmneal Pharmaceuticals NY LLCe2e24b14-0169-4028-828a-894ad3c2ba552026-05-12Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NADOLOLNADOLOLBryant Ranch Prepack64a788d0-b7f0-4f39-8adb-ab68870ecfa52026-04-29Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLBryant Ranch Prepack2d126308-c58d-4950-9dcb-eaadb1a2054f2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLGolden State Medical Supply, Inc.33dcfdb9-1741-71e1-e063-6294a90afdff2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLUNICHEM PHARMACEUTICALS (USA), INC.5a8014fb-9b65-4457-bfd5-0ab7e6de330e2026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
NadololNADOLOLAmerican Health Packaging9e8e129d-cb17-45fc-b3e2-2600c01664632025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
NadololNADOLOLBluePoint Laboratories15822faf-6924-4a63-a4e1-6058b308708c2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
NadololNADOLOLZydus Lifesciences Limited29433c5a-51c6-4fb9-9174-1b1c616c9e572024-12-05Exact identifier
unii: FEN504330V
NadololNADOLOLBryant Ranch Prepack0d66548a-231e-4104-be0c-c6ce1586b46c2024-10-02Warnings, Adverse reactionsExact identifier
unii: FEN504330V
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
NadololNADOLOLBluePoint Laboratories0a2acdc0-aab6-462e-a377-67a0f3d55ec62024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FEN504330V
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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