FDA.reportPublic FDA data

NDC 80425-0265-01 - Promethazine 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
80425-0265
Requested NDC
80425-0265-01
Package NDCs from labels
80425-0265-1, 80425-0265-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0265-1Promethazine Hydrochloride20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0265PROMETHAZINE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_f4c23037-e415-7604-e053-2995a90a5bb6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0265-1EA - Each80425-0265a8a79a83-5300-44ec-b662-8b9ae5ac1a6312023-04-07

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 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6f7e47cc-f823-4336-8107-f980e30496172025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.1b1cee64-c0b5-4da6-92d0-1769350a51812025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEATLANTIC BIOLOGICALS CORP.f8fb13e3-bc09-4004-a911-a38b6bbb00582025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine DMPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPAI Holdings, LLC dba PAI Pharma1d47280d-28c9-4701-8c5f-a6e6b524083b2025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAsclemed USA, Inc.702eb7c0-db4c-4729-b69e-99f64c63c7bd2025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXttrium Laboratories, Inc.302bfea2-d403-d315-e063-6294a90a37dd2025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEXttrium Laboratories, Inc30c9d769-bc74-04d2-e063-6294a90a665a2025-04-07Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKesin Pharma Corporation28793bd2-bd40-4571-e063-6394a90ae7892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.74834e1b-0d90-0542-e053-2991aa0aa1ef2025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC2d996287-9eed-265a-e063-6294a90a69692025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992475
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONNuCare Pharmaceuticals,Inc.0b7bfbab-decb-970c-e063-6394a90a50ef2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.12400c65-f93b-47a5-8167-1fb14337130b2025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 992475
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4c23037-e415-7604-e053-2995a90a5bb62024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA040596
ndc (package): 80425-0265-1
ndc (product): 80425-0265
ndc11 (package): 80425026501
rxcui: 992447
spl id: 2a9bad62-b2fe-697c-e063-6294a90aa395
spl set id: f4c23037-e415-7604-e053-2995a90a5bb6
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Lifesciences Limited4eaa8291-9cde-4205-857b-925ea8d618ba2024-12-04Exact identifier
application number: ANDA040596
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Phenylephrine HydrochloridePROMETHAZINE AND PHENYLEPHRINEAmneal Pharmaceuticals LLCcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed42024-10-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAmneal Pharmaceuticals LLC6081c216-0bed-40f0-8732-f999647003d52024-10-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLC05907a49-537f-4bf2-8a5f-5e905f19fece2024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions6aa6bfcc-024b-4ee2-a586-6c4ca879cea42024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions69eea039-0098-4e2f-a832-152583b16f052024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb7137912-d119-4899-9c93-09c1c625f2902024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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