FDA.reportPublic FDA data

NDC 69238-1124-09 - 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
69238-1124
Requested NDC
69238-1124-09
Package NDCs from labels
69238-1124-3, 69238-1124-9, 69238-1124-1, 69238-1124-09
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nadolol - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2026-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1124-1Nadolol1000 in 1 BOTTLETABLET10009
69238-1124-3Nadolol30 in 1 BOTTLETABLET309
69238-1124-9Nadolol90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1124NADOLOL TABLET [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, Legacy NDC, 3 package rows20241011_e2e24b14-0169-4028-828a-894ad3c2ba55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1124-9EA - Each69238-112459a05c5a-b29f-452c-a125-b46f3811855c12017-11-06

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 5 · 91 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
NadololNADOLOLBluePoint Laboratoriesf11553f1-18ec-41b0-a7ad-1c9f21ef2c9f2026-09-07Warnings, Adverse reactionsExact identifier
rxcui: 198007
rxcui: 198006
rxcui: 198008
unii: FEN504330V
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
NadololNADOLOLAmerican Health Packaging9acc0c81-4145-43cc-b31a-7b1e3313259d2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198007
rxcui: 198006
unii: FEN504330V
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
NadololNADOLOLA-S Medication Solutions4580b85b-437c-4c52-bf31-5976968ecd5c2026-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA208832
rxcui: 198006
unii: FEN504330V
NadololNADOLOLBryant Ranch Prepackc154d99c-e4fb-41d0-8fac-e1982672e8d72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198008
unii: FEN504330V
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
NadololNADOLOLREMEDYREPACK INC.8a224f90-24a5-411e-ac26-6496a1930f3a2026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 198007
unii: FEN504330V
NadololNADOLOLAmneal Pharmaceuticals NY LLCe2e24b14-0169-4028-828a-894ad3c2ba552026-05-12Warnings, Adverse reactionsExact identifier
application number: ANDA208832
ndc (package): 69238-1125-3
ndc (package): 69238-1124-9
ndc (package): 69238-1124-1
ndc (package): 69238-1124-3
ndc (package): 69238-1125-9
ndc (package): 69238-1123-3
ndc (package): 69238-1125-1
ndc (package): 69238-1123-9
ndc (package): 69238-1123-1
ndc (product): 69238-1123
ndc (product): 69238-1124
ndc (product): 69238-1125
ndc11 (package): 69238112409
rxcui: 198007
rxcui: 198006
rxcui: 198008
spl id: c6c87588-2b1f-4319-97bf-d045e884a80f
spl set id: e2e24b14-0169-4028-828a-894ad3c2ba55
unii: FEN504330V
NADOLOLNADOLOLBryant Ranch Prepack64a788d0-b7f0-4f39-8adb-ab68870ecfa52026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 198008
unii: FEN504330V
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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