FDA.reportPublic FDA data

NDC 50090-4453-01 - 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
50090-4453
Requested NDC
50090-4453-01
Package NDCs from labels
50090-4453-0, 50090-4453-1, 50090-4453-5, 50090-4453-6, 50090-4453-9, 50090-4453-01
Manufacturer
A-S Medication Solutions
Effective date
2023-05-08
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 Solutions2023-05-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4453-02023-02-07PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-12023-02-07PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-52023-02-07PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-62023-02-07PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-92023-02-07PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-02023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-12023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-52023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-62023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
50090-4453-92023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4453-0PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLETABLET1210
50090-4453-1PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET1010
50090-4453-5PROMETHAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET6010
50090-4453-6PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLETABLET2010
50090-4453-9PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4453PROMETHAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 5 package rows20230510_2c9a4767-23c4-4a1c-bb4c-2bad1351c270.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4453-0EA - Each50090-44533ffe64ed-ce71-4fd7-909e-daa67e6162fe12023-06-06
50090-4453-1EA - Each50090-44538d71d7c6-5e0e-4232-a875-282f6f8b3aa012023-06-06
50090-4453-5EA - Each50090-4453c08f392c-6799-4aa4-962d-f706acd1b2c012023-06-06
50090-4453-6EA - Each50090-4453c0815672-d3aa-436f-b6f2-ca6ca1b0a20312023-06-06
50090-4453-9EA - Each50090-4453e1346423-ed2b-4b72-aeb5-59b5a408002912023-06-06

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 2 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack709519cb-d124-4469-b329-b67e1bba214b2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.81fd29a9-c090-49ba-8b48-bd3656ca0c922026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA040712
ndc (product): 10702-003
rxcui: 992475
rxcui: 992447
rxcui: 992438
spl id: 4ceccb65-dd65-461c-e063-6294a90afcda
spl set id: 7a137adf-39b7-4b14-80da-c3cac9ad562a
unii: R61ZEH7I1I
PhenerganPROMETHAZINE HCLDirect_Rxeec705f7-123a-7926-e053-2a95a90af46d2026-03-05Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.adb04635-584f-4fef-98ca-2574be312a732026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCf6ca1097-1c75-c682-e053-6294a90a2bd62026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECosette Pharmaceuticals, Inc.3b02cda4-9b24-79c9-e063-6294a90af5b92025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECranbury Pharmaceuticals, LLC785c605e-1907-4fac-8b69-d504a2076f8e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECranbury Pharmaceuticals, LLCa8b57027-a4b8-4149-93e8-aa3e7a6d6dc32025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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