FDA.reportPublic FDA data

NDC 50090-4875-00 - 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
50090-4875
Requested NDC
50090-4875-00
Package NDCs from labels
50090-4875-0, 50090-4875-00
Manufacturer
A-S Medication Solutions
Effective date
2024-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2024-10-21HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4875-02023-02-06C16284748780-1f386c64a-4487-0266-e053-dadaa90a7c1aPromethazine Hydrochloride Tablets USP
50090-4875-02023-01-30C16284748780-1f386c64a-4487-0266-e053-dadaa90a7c1aPromethazine Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4875-0Promethazine Hydrochloride12 in 1 BOTTLETABLET128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4875PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20241023_69eea039-0098-4e2f-a832-152583b16f05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4875-0EA - Each50090-4875e9864560-ec3f-4e07-8f39-89a2b1fa865112024-11-05

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 3 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDECranbury Pharmaceuticals, LLCd32ea9db-11d4-400d-b7ef-dd0ec01b796d2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProPharma Distribution45b09a50-dab2-e83d-e063-6394a90aa8132025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP69934bbb-922c-4752-b253-f2f07340de8d2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions46b869e2-9305-43ae-bb15-919a6d09b6ff2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaginga8fe4bc5-961b-4441-b8e2-ef93e4e137b62025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaging57b4bf23-c563-4357-9dcf-066cbc1280e42025-11-13Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.d7675718-0a57-41ff-a771-79afc12150aa2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.c525cb2c-9a01-4a9b-ad2c-08630719953d2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLCe16238dc-9292-49ac-b80f-8afeccb88bc52025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHEGANPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe972025-10-20Boxed warning, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7d766cf7-a21c-4eaf-bbdc-00f2939ef19a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECosette Pharmaceuticals, Inc.e7b336d9-b1df-4a08-9b67-754346d365f42025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions87f9e9fb-5433-478b-9f23-e16883a9d2a92025-09-23Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMajor Pharmaceuticals4cee8622-7d59-4794-8e32-54f7aac1d9232025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBluePoint Laboratories44cd6d46-fbb9-4836-9426-d8ce2cb6d66d2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI Pharmaceuticals, Inc.a52e210f-b99d-493e-b679-ec565c6ff72d2025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma7a186bcd-ab8c-4695-8289-4cd33bb551cf2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.13d9e59d-eadb-41d5-9f47-9c11a6efb31c2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d545105f-27dc-4820-b0b1-fcf17e0be0f02025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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