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 5 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.84899861-8fed-536d-e053-2991aa0a42b22024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsa4fbc2d8-19b3-4556-b0b9-6e7a14cd4c362024-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepack07914b6e-c40f-44be-a1db-8724c70f99b62024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackea490539-007b-47b1-bef9-22de02ae7c642024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacka4b3da5b-1129-43c2-bf22-3a29c3fae1162024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8749824b-6d66-430d-e053-2995a90a2db82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7e5715cf-056f-4095-e053-2991aa0ad3e52024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4bf3912c-8339-401e-9711-dad6acf15f112024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.481866da-a712-48a5-853f-8e84aacaab6d2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEBryant Ranch Prepackdf2c24ba-1c88-4ec3-b2a1-801358ec645c2024-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b0d5abba-6fae-4f3c-b990-dd9c83c7b5a92024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.365138a6-28d8-4881-a3e9-02c80aaf83e82024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackda246971-20b8-b46e-8366-9700d3604cf12024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.b4985d9d-1aa0-4b36-bc98-6a5410ad9bad2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a2024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst7447e8c6-c198-cd2d-e053-2a91aa0a38952024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.b6f6698f-f23c-452a-9b38-bbb96ab88ae42024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.1d02d52b-84bb-4e81-b352-125029eb39f62024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsa7b1e8b2-6f20-4096-87c7-cf349ed4f7b92023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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