FDA.reportPublic FDA data

NDC 80425-0463-01 - Propranolol 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
80425-0463
Requested NDC
80425-0463-01
Package NDCs from labels
80425-0463-1, 80425-0463-2, 80425-0463-3, 80425-0463-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Propranolol Hydrochloride - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0463-1Propranolol Hydrochloride30 in 1 BOTTLETABLET301
80425-0463-2Propranolol Hydrochloride60 in 1 BOTTLETABLET601
80425-0463-3Propranolol Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0463PROPRANOLOL HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241229_29acc74e-79b5-f668-e063-6394a90aef9b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0463-1EA - Each80425-04630481d4b8-c9e5-4b77-8b43-f38d3062f84912025-02-10
80425-0463-2EA - Each80425-04636cd89b3f-262e-430f-b359-87ef75abe95012025-02-10
80425-0463-3EA - Each80425-0463c348420c-25bd-4916-860a-bed5b933c26112025-02-10

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 5 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsbe55cf2d-c2f8-4781-b2ef-fd607324265c2025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 856519
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.179e31a7-9956-4fba-9e9a-2ca28d37d42b2025-08-04Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAsclemed USA, Inc.d08dbabc-8ca4-426e-a9fd-e7914a27883c2025-05-31Warnings, Adverse reactionsExact identifier
rxcui: 856519
rxcui: 856578
rxcui: 856556
rxcui: 856457
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.85973689-bb21-483f-becb-c5c8bfb056582025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackfc1a2e79-3c3b-4e5a-8e75-0fd7abbac5a02025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 856578
unii: F8A3652H1V
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC74dc9949-010c-4f2c-9aef-63ab466ba6572025-02-28Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856457
unii: F8A3652H1V
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect Rxd7c0cc12-6d2d-7146-e053-2995a90a85a42025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDIRECT RXa834d1cf-72fc-93bf-e053-2995a90a61912025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ed10dd67-5987-4191-b2d3-9dcf40340caa2025-01-03Warnings, Adverse reactionsExact identifier
rxcui: 856457
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ace768-8fef-482b-e063-6394a90aa2ac2024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29acc74e-79b5-f668-e063-6394a90aef9b2024-12-19Warnings, Adverse reactionsExact identifier
application number: ANDA071972
ndc (package): 80425-0463-1
ndc (package): 80425-0463-3
ndc (package): 80425-0463-2
ndc (product): 80425-0463
ndc11 (package): 80425046301
rxcui: 856448
spl id: 29acc753-9434-f4ef-e063-6294a90ac68c
spl set id: 29acc74e-79b5-f668-e063-6394a90aef9b
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack360de855-b8be-409f-9ca6-d0a0368af1742024-12-09Warnings, Adverse reactionsExact identifier
rxcui: 856519
rxcui: 856578
rxcui: 856457
rxcui: 856448
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack5ee3776f-9d02-4d98-bc9d-e810c87961c32024-11-27Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1c275a7b-2e85-4990-b3ad-6c675d6c2d7b2024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 856556
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackb27ade81-8b41-4394-aec1-d23370bfa3b72024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 856519
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack16291f1b-1ce4-480a-a1fc-c20bbac4cbe72024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 856578
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackfce3539f-82f3-4bb5-a6ba-c38171c67c062024-10-10Warnings, Adverse reactionsExact identifier
rxcui: 856578
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba102024-10-09Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackd655fb2d-0cfd-4aad-8770-5decdcee10b22024-10-09Warnings, Adverse reactionsExact identifier
rxcui: 856519
unii: F8A3652H1V

Reported adverse events (FAERS/openFDA)#

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