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 4 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCf76b7edc-6d7d-9cba-e053-6294a90a035c2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEIpca Laboratories Limited9288191e-4d07-4e37-ab66-7b9de9321cf32025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 856519
rxcui: 856578
rxcui: 856556
rxcui: 856457
rxcui: 856448
unii: F8A3652H1V
PropranololPROPRANOLOL HYDROCHLORIDEProPharma Distribution45b0aaf0-df6c-7db0-e063-6294a90a91352025-12-11Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPe289160e-0f3a-4667-b8ba-9c93fbf21a302025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
PROPRANOLOLPROPRANOLOL HYDROCHLORIDEHenry Schein, Inc.e586996d-9035-4ef4-8c8d-06e70a02577f2025-11-07Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa62025-10-30Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack96fa108c-b31c-445c-b978-c848cac594192025-10-30Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack5cf8d0a4-4e02-48f0-8d1f-564357b250c52025-10-30Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepacke0959293-321d-4427-8bb7-8e74b03464d62025-10-13Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.40333bee-749f-0b43-e063-6394a90a149c2025-10-01Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEActavis Pharma, Inc.a4edba76-29b8-41fb-bf0b-d4633abba0032025-09-26Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmerican Health Packaging015b5e4f-3228-4259-b419-e0e49694a0582025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcd5cf31d-dade-425f-a32c-2e681a0087872025-09-19Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack82a4d30b-5018-453d-a8ab-fef2e3266f692025-09-11Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackc5ad5449-b93e-4f26-977b-c66466d8ac6f2025-09-10Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECoupler LLC3e50045f-abdf-3b78-e063-6394a90a4ba02025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 856556
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1d79ba59-6346-46c0-8e63-470e2069238e2025-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856457
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackc139587f-fdfa-4efe-a39e-452f7c39e6572025-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856519
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepacka21eb31b-db50-47a5-8f4c-315c2a842c8b2025-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions62ef3d7d-c87f-4d2f-af12-47d50e8b54882025-08-08Warnings, Adverse reactionsExact identifier
rxcui: 856457
unii: F8A3652H1V

Reported adverse events (FAERS/openFDA)#

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