FDA.reportPublic FDA data

NDC 0591-3158-83 - Promethazine HCl

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
0591-3158
Requested NDC
0591-3158-83
Package NDCs from labels
0591-3158-54, 0591-3158-83
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HCl INJECTION USP Rx OnlyWatson Laboratories, Inc.2006-04-05HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3158-54Promethazine HCl1 mL in 1 AMPULEINJECTION11
0591-3158-83Promethazine HCl25 in 1 CARTONINJECTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3158PROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]12 package rows20060821_AAAF4D12-4E68-45F9-AC10-2238480A0160.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine hydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
Glacial Acetic AcidINACTIVE INGREDIENTPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
PhenolINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
Sodium Acetate, TrihydrateINACTIVE INGREDIENTPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
Sodium MetabisulfiteINACTIVE INGREDIENTPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WATSON LABORATORIES, INC.]1

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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProPharma Distribution45b09a50-dab2-e83d-e063-6394a90aa8132025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.d7675718-0a57-41ff-a771-79afc12150aa2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.c525cb2c-9a01-4a9b-ad2c-08630719953d2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992858
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.13d9e59d-eadb-41d5-9f47-9c11a6efb31c2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d545105f-27dc-4820-b0b1-fcf17e0be0f02025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6f7e47cc-f823-4336-8107-f980e30496172025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4bf3912c-8339-401e-9711-dad6acf15f112024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.481866da-a712-48a5-853f-8e84aacaab6d2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b0d5abba-6fae-4f3c-b990-dd9c83c7b5a92024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.365138a6-28d8-4881-a3e9-02c80aaf83e82024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
rxcui: 992858
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a2024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992858
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst7447e8c6-c198-cd2d-e053-2a91aa0a38952024-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.b6f6698f-f23c-452a-9b38-bbb96ab88ae42024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992858
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.1d02d52b-84bb-4e81-b352-125029eb39f62024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC677b5fc5-94be-638b-e053-2991aa0a7f972023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdc8b50de-e4f6-607f-e053-2995a90a29022023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc930985b-bba3-4f3a-a1ae-1d808670efde2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992858

Reported adverse events (FAERS/openFDA)#

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