FDA.reportPublic FDA data

NDC 68788-7886-02 - 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
68788-7886
Requested NDC
68788-7886-02
Package NDCs from labels
68788-7886-1, 68788-7886-8, 68788-7886-2, 68788-7886-3, 68788-7886-02
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride Tablets USPPreferred Pharmaceuticals Inc.2026-08-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7886-1Promethazine Hydrochloride10 in 1 BOTTLETABLET105
68788-7886-2Promethazine Hydrochloride20 in 1 BOTTLETABLET205
68788-7886-3Promethazine Hydrochloride30 in 1 BOTTLETABLET305
68788-7886-8Promethazine Hydrochloride12 in 1 BOTTLETABLET125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7886PROMETHAZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240805_974208c8-4aad-4fb9-991b-cf3085034272.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7886-1EA - Each68788-7886e1e113f5-e7c1-4da8-ad91-54e397970e0712021-06-02
68788-7886-2EA - Each68788-78867e016b6b-33a5-43c4-9f50-091f4493204312021-06-02
68788-7886-3EA - Each68788-7886326eb97b-8ce5-4913-8d4a-48560fc358c712021-06-02
68788-7886-8EA - Each68788-7886884d713b-7e43-49f3-9140-bd66b9b5e4cb12021-06-02

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 · 123 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
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDERedpharm Drug5a797d11-19b0-fd33-e063-6394a90a4d582026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.974208c8-4aad-4fb9-991b-cf30850342722026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
ndc (package): 68788-7886-1
ndc (package): 68788-7886-2
ndc (package): 68788-7886-3
ndc (package): 68788-7886-8
ndc (product): 68788-7886
ndc11 (package): 68788788602
rxcui: 992447
spl id: 1f9094a1-c798-4011-8c76-074daaffe7b8
spl set id: 974208c8-4aad-4fb9-991b-cf3085034272
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC5991de26-891a-153a-e063-6294a90a46332026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5590f356-0904-58f6-e063-6294a90a6ad52026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6bcaa89f-5f14-dc45-e053-2a91aa0aac542026-07-30Warnings, Adverse reactionsExact identifier
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
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.9e4e57fa-4ce3-4b7b-be5a-381801ed03862026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDESportpharm LLC4156e780-7ecf-bcae-e063-6394a90a2ae22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
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
application number: ANDA040596
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 992447
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
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 992475
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsExact identifier
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.