FDA.reportPublic FDA data

NDC 67296-0198-04 - 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
67296-0198
Requested NDC
67296-0198-04
Package NDCs from labels
67296-0198-4, 67296-0198-2, 67296-0198-1, 67296-0198-04
Manufacturer
Redpharm Drug
Effective date
2026-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - Redpharm DrugRedpharm Drug2026-09-02HUMAN PRESCRIPTION DRUG LABEL
Promethazine 25mgRedPharm Drug, Inc.2024-06-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67296-0198-12024-06-13Promethazine 25mg
67296-0198-22024-06-13Promethazine 25mg
67296-0198-12023-01-30Promethazine 25mg
67296-0198-22023-01-30Promethazine 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0198-1Promethazine Hydrochloride15 in 1 BOTTLETABLET155
67296-0198-2Promethazine Hydrochloride20 in 1 BOTTLETABLET205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0198PROMETHAZINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]5Current NDC, Legacy NDC, 2 package rows20240615_891a74cf-c4df-975d-e053-2a95a90a6872.zip

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 · 124 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
1ac473ff-a871-5823-e063-6294a90a199c891a74cf-c4df-975d-e053-2a95a90a68722024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 1ac473ff-a871-5823-e063-6294a90a199c
spl set id: 891a74cf-c4df-975d-e053-2a95a90a6872
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

Reported adverse events (FAERS/openFDA)#

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