FDA.reportPublic FDA data

NDC 63629-1591-01 - 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
63629-1591
Requested NDC
63629-1591-01
Package NDCs from labels
63629-1591-1, 63629-1591-2, 63629-1591-3, 63629-1591-5, 63629-1591-6, 63629-1591-7, 63629-1591-8, 63629-1591-9, 63629-1591-0, 63629-1591-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1591-0Promethazine Hydrochloride30 in 1 BOTTLETABLET301023
63629-1591-1Promethazine Hydrochloride12 in 1 BOTTLETABLET121023
63629-1591-2Promethazine Hydrochloride4 in 1 BOTTLETABLET41023
63629-1591-3Promethazine Hydrochloride2 in 1 BOTTLETABLET21023
63629-1591-5Promethazine Hydrochloride6 in 1 BOTTLETABLET61023
63629-1591-6Promethazine Hydrochloride10 in 1 BOTTLETABLET101023
63629-1591-7Promethazine Hydrochloride40 in 1 BOTTLETABLET401023
63629-1591-8Promethazine Hydrochloride20 in 1 BOTTLETABLET201023
63629-1591-9Promethazine Hydrochloride60 in 1 BOTTLETABLET601023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1591PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1023Current NDC, Legacy NDC, 9 package rows20240517_da246971-20b8-b46e-8366-9700d3604cf1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1591-1EA - Each63629-15915a0aa608-8e19-4278-94d2-70c2739dba3212012-07-24
63629-1591-2EA - Each63629-159188adf0f7-8643-4e72-b5d8-ea297103d51f12012-07-24
63629-1591-3EA - Each63629-1591d8eda1d0-5af1-4cd3-a621-38b420fd177f12012-07-24
63629-1591-4EA - Each63629-1591ea969485-0eb8-4f3c-aaf2-117e4eec4c8612012-07-24
63629-1591-5EA - Each63629-15913d3a2dbd-edec-402a-b6c7-b3ffd17065fc12012-07-24
63629-1591-6EA - Each63629-15910d97da75-b080-478e-9a9a-d9ad1ba6df4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1001

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 2 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack709519cb-d124-4469-b329-b67e1bba214b2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.81fd29a9-c090-49ba-8b48-bd3656ca0c922026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
PhenerganPROMETHAZINE HCLDirect_Rxeec705f7-123a-7926-e053-2a95a90af46d2026-03-05Warnings, Adverse reactionsExact identifier
application number: ANDA040596
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.adb04635-584f-4fef-98ca-2574be312a732026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992438
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCf6ca1097-1c75-c682-e053-6294a90a2bd62026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECosette Pharmaceuticals, Inc.3b02cda4-9b24-79c9-e063-6294a90af5b92025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECranbury Pharmaceuticals, LLC785c605e-1907-4fac-8b69-d504a2076f8e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECranbury Pharmaceuticals, LLCa8b57027-a4b8-4149-93e8-aa3e7a6d6dc32025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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