FDA.reportPublic FDA data

promethazine HCl 50 MG Oral Tablet

RxCUI
992475
RxNorm name
promethazine HCl 50 MG Oral Tablet
Display name
promethazine HCl 50 MG Oral Tablet
Full name
promethazine HCl 50 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDESportpharm LLC4156e780-7ecf-bcae-e063-6394a90a2ae22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEASCLEMED USA INC.4d30e587-6d59-4cf5-ab45-c7639f759df92026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 992475
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBluePoint Laboratories44cd6d46-fbb9-4836-9426-d8ce2cb6d66d2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC2d996287-9eed-265a-e063-6294a90a69692025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.12400c65-f93b-47a5-8167-1fb14337130b2025-01-07Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Lifesciences Limited4eaa8291-9cde-4205-857b-925ea8d618ba2024-12-04Exact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLC05907a49-537f-4bf2-8a5f-5e905f19fece2024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.b4985d9d-1aa0-4b36-bc98-6a5410ad9bad2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c0c0d4f0-8396-485b-a585-71df01491f6f2023-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEActavis Pharma, Inc.a32255f0-0077-489e-bdc6-869aca8cd4342016-12-01Warnings, Adverse reactionsExact identifier
rxcui: 992475

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 16 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
12400c65-f93b-47a5-8167-1fb14337130bpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]223PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only20250107
f93ca67d-362a-473f-8296-2952da77c074promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]220PROMETHAZINE HYDROCHLORIDE TABLETS, USP20260522
05907a49-537f-4bf2-8a5f-5e905f19fecepromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]219PROMETHAZINE HYDROCHLORIDE TABLETS, USP Rx only20241030
0b5734b8-6a52-44ff-ac29-9a91a4335394promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]218Promethazine Hydrochloride Tablets, USP (12.5 mg, 25 mg and 50 mg) Rx only20251220
7a137adf-39b7-4b14-80da-c3cac9ad562apromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]213PROMETHAZINE HYDROCHLORIDE TABLETS, USP20260313
44cd6d46-fbb9-4836-9426-d8ce2cb6d66dpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]29Promethazine Hydrochloride Tablets, USP20250912
c0c0d4f0-8396-485b-a585-71df01491f6fpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]28Promethazine Hydrochloride Tablets USP20231107
a32255f0-0077-489e-bdc6-869aca8cd434promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]28Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only20161201
4eaa8291-9cde-4205-857b-925ea8d618bapromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]27Promethazine Hydrochloride Tablets USP20241204
5cc95465-0134-d346-e053-2991aa0a23bbpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]23PROMETHAZINE HYDROCHLORIDE 50mg20230111
4156e780-7ecf-bcae-e063-6394a90a2ae2promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]22Promethazine Hydrochloride Tablets USP20260424
4d30e587-6d59-4cf5-ab45-c7639f759df9promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]21Promethazine Hydrochloride Tablets USP20251021
2d996287-9eed-265a-e063-6294a90a6969promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]21Promethazine Hydrochloride Tablets, USP20250207
b4985d9d-1aa0-4b36-bc98-6a5410ad9badpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]21Promethazine Hydrochloride Tablets USP20240226
65b2f396-666b-4b08-890f-19429844e74bpromethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]21Promethazine Hydrochloride Tablets USP20110104
ff1dddab-72a0-4125-859e-554bece2d2b3promethazine HCl 50 MG Oral Tablet [PSN] · promethazine hydrochloride 50 MG Oral Tablet [SCD]2120100603