FDA.reportPublic FDA data

NDC 68071-4737-03 - 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
68071-4737
Requested NDC
68071-4737-03
Package NDCs from labels
68071-4737-6, 68071-4737-3, 68071-4737-2, 68071-4737-03
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HYDROCHLORIDE TABLETS, USPNuCare Pharmaceuticals,Inc.2026-06-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-12PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2024-06-12PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2023-01-30PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2021-02-17PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2021-02-17PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP
2021-01-29PROMETHAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4737-3PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
68071-4737-6PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4737PROMETHAZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240614_804e2525-d61f-7bed-e053-2991aa0a5daa.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 1 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDERedpharm Drug5a797d11-19b0-fd33-e063-6394a90a4d582026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.974208c8-4aad-4fb9-991b-cf30850342722026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC5991de26-891a-153a-e063-6294a90a46332026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5590f356-0904-58f6-e063-6294a90a6ad52026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6bcaa89f-5f14-dc45-e053-2a91aa0aac542026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992447
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONATLANTIC BIOLOGICALS CORP.3983d6d3-8bf4-4a88-962f-9bf72fd6e6852026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC55f618d1-4466-3200-e063-6394a90a89a82026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.9e4e57fa-4ce3-4b7b-be5a-381801ed03862026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDESportpharm LLC4156e780-7ecf-bcae-e063-6394a90a2ae22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEASCLEMED USA INC.4d30e587-6d59-4cf5-ab45-c7639f759df92026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA040712
ndc (package): 68071-4737-3
ndc (package): 68071-4737-2
ndc (package): 68071-4737-6
ndc (product): 68071-4737
ndc11 (package): 68071473703
rxcui: 992447
spl id: 557ecafd-4236-de90-e063-6294a90a6798
spl set id: 804e2525-d61f-7bed-e053-2991aa0a5daa
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAdvagen Pharma Ltd8b60eff2-5759-4bc3-ac16-5ff80aa153a02026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECamber Pharmaceuticals, Inc.6a2cd2d6-6e0f-4b2d-be7a-8b99627f44532026-06-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacke6d940f8-fa1a-4a75-b4fc-2cbbaf7a04882026-06-05Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992475
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA040712
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAtlantic Biologicals Corp.5022379d-05ef-63f2-e063-6294a90a21892026-04-23Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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