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 7 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutions325dda2c-ecd9-4368-8779-7ff505b2b1382024-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856457
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61a348-0fe9-71c0-e053-2a95a90a9a4c2024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsd1110a10-a7f4-4295-9e94-8fbb56f77f672024-02-27Warnings, Adverse reactionsExact identifier
application number: ANDA071972
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.11873816-5789-e951-e063-6294a90ad16e2024-02-16Warnings, Adverse reactionsExact identifier
rxcui: 856519
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP1d7c1de3-3cf4-4b1e-bdcc-55f423c880012024-02-01Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
propranolol hydrochloridePROPRANOLOL HYDROCHLORIDEA-S Medication Solutionsd1cfdb57-0b04-43f7-bd10-c585f77385b32023-08-09Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMedical Purchasing Solutions, LLC693569bd-6053-5b3e-e053-2a91aa0a6e9c2023-05-23Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
PropranololPROPRANOLOL HYDROCHLORIDEMedical Purchasing Solutions, LLC9e50d1ee-b7f3-e549-e053-2995a90a4a862023-05-09Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackcf393c74-381f-4b60-8479-b0763bc71e8e2023-04-03Warnings, Adverse reactionsExact identifier
rxcui: 856457
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP91055555-6967-4b6a-b5c8-5211ec18d2c82023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 856519
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP968353ed-eb79-4f96-9569-3efb220fc3882023-02-01Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPe4009ade-155b-4d28-8a8d-555db68bf8b02023-02-01Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAMICI PHARMACEUTICALS LLC8efc9fc6-6db0-43c9-892b-7423a9ba679f2023-01-24Warnings, Adverse reactionsExact identifier
rxcui: 856519
rxcui: 856578
rxcui: 856556
rxcui: 856457
rxcui: 856448
unii: F8A3652H1V
PropranololPROPRANOLOL HYDROCHLORIDEFresenius Kabi USA, LLCf14ea537-dd5c-4c78-9037-9a85e9e610ef2023-01-12Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPec9e45ed-4c62-4075-b40e-2a9e40ac682b2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 856457
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPharmaceutical Associates, Inc.ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb2022-06-22Warnings, Adverse reactionsExact identifier
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPea86beb4-33c8-4841-a742-82212ce716d22022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 856448
unii: F8A3652H1V
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3c05ab1f-05b0-494a-b640-667e7cf517a12021-07-01Warnings, Adverse reactionsExact identifier
rxcui: 856457
unii: F8A3652H1V

Reported adverse events (FAERS/openFDA)#

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