FDA.reportPublic FDA data

NDC 70518-1306-8 - 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
70518-1306
Requested NDC
70518-1306-8
Package NDCs from labels
70518-1306-0, 70518-1306-1, 70518-1306-2, 70518-1306-3, 70518-1306-4, 70518-1306-5, 70518-1306-6, 70518-1306-8, 70518-1306-7
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride Tablets USPREMEDYREPACK INC.2026-07-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1306-0Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-1Promethazine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET621
70518-1306-2Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1521
70518-1306-3Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-4Promethazine Hydrochloride30 in 1 BLISTER PACKTABLET3021
70518-1306-5Promethazine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1521
70518-1306-6Promethazine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET1021
70518-1306-7Promethazine Hydrochloride50 in 1 BOXTABLET5021
70518-1306-8Promethazine Hydrochloride1 in 1 POUCHTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1306PROMETHAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 9 package rows20250510_9e4e57fa-4ce3-4b7b-be5a-381801ed0386.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 6 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb54439a3-1d01-4c5f-8508-731790ae215b2023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHEGANPROMETHAZINE HYDROCHLORIDECosette Pharmaceuticals, Inc.5f079815-f48b-8b21-2130-7f791d967c9a2023-11-30Boxed warning, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHEGANPROMETHAZINE HYDROCHLORIDECosette Pharmaceuticals, Inc.636bb9bc-0cc5-4d6a-85be-6471acf01ffc2023-11-30Boxed warning, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c0c0d4f0-8396-485b-a585-71df01491f6f2023-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
ndc (product): 68382-041
rxcui: 992475
rxcui: 992447
rxcui: 992438
spl id: d461a206-0842-428f-ad9b-a4aac8193fe9
spl set id: c0c0d4f0-8396-485b-a585-71df01491f6f
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb96904e7-cc67-4abc-b946-8423f3f897ff2023-10-24Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc0a68671-407b-4840-9662-04f168cff1cb2023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide OralPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORALA-S Medication Solutions9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252023-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC677b5fc5-94be-638b-e053-2991aa0a7f972023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutions2c9a4767-23c4-4a1c-bb4c-2bad1351c2702023-05-08Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdc8b50de-e4f6-607f-e053-2995a90a29022023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LPdcb1694a-8451-403c-b848-edb89ba170202023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC32022e66-6f76-430a-8ad2-1e9e2872fee12023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEQUAGEN PHARMACEUTICALS LLC9aca56ec-28f8-4679-9f90-ec3e82deb9ac2023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions87429921-00d2-42c7-9e99-600e8075b8ce2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc930985b-bba3-4f3a-a1ae-1d808670efde2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP59b906c6-2ccc-416e-b3ee-db09bf5531462023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.ba7d9e82-9b13-4607-b2f9-25e575b8c73b2022-11-05Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PromethazinePROMETHAZINEPharmPak, Inc.4f681538-7ac4-484c-9e6d-b571d73b9e0b2022-10-08Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONProficient Rx LP68a4c521-6db0-4e94-9906-96e96e2513012022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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