FDA.reportPublic FDA data

NDC 68084-155-11 - 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
68084-155
Requested NDC
68084-155-11
Package NDCs from labels
68084-155-11, 68084-155-01
Manufacturer
American Health Packaging
Effective date
2025-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - American Health PackagingAmerican Health Packaging2025-11-13HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Cardinal HealthCardinal Health2018-12-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-155-01Promethazine Hydrochloride100 in 1 CARTONTABLET10010
68084-155-11Promethazine Hydrochloride1 in 1 BLISTER PACKTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-155PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20240415_a8fe4bc5-961b-4441-b8e2-ef93e4e137b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-155-01EA - Each68084-155daf328c4-4899-42b4-ba38-85588187be7112012-07-24
68084-155-11EA - Each68084-155884ba9b1-fb4d-48cf-bb19-4938ca4e8c6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4

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 3 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDECranbury Pharmaceuticals, LLCd32ea9db-11d4-400d-b7ef-dd0ec01b796d2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProPharma Distribution45b09a50-dab2-e83d-e063-6394a90aa8132025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP69934bbb-922c-4752-b253-f2f07340de8d2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions46b869e2-9305-43ae-bb15-919a6d09b6ff2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaginga8fe4bc5-961b-4441-b8e2-ef93e4e137b62025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
ndc (package): 68084-155-01
ndc (package): 68084-155-11
ndc (product): 68084-155
ndc11 (package): 68084015511
rxcui: 992447
spl id: 437dac5e-3b6a-4c85-e063-6394a90a0d43
spl set id: a8fe4bc5-961b-4441-b8e2-ef93e4e137b6
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaging57b4bf23-c563-4357-9dcf-066cbc1280e42025-11-13Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992438
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.d7675718-0a57-41ff-a771-79afc12150aa2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.c525cb2c-9a01-4a9b-ad2c-08630719953d2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLCe16238dc-9292-49ac-b80f-8afeccb88bc52025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
PROMETHEGANPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe972025-10-20Boxed warning, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7d766cf7-a21c-4eaf-bbdc-00f2939ef19a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECosette Pharmaceuticals, Inc.e7b336d9-b1df-4a08-9b67-754346d365f42025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions87f9e9fb-5433-478b-9f23-e16883a9d2a92025-09-23Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMajor Pharmaceuticals4cee8622-7d59-4794-8e32-54f7aac1d9232025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBluePoint Laboratories44cd6d46-fbb9-4836-9426-d8ce2cb6d66d2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040596
rxcui: 992475
rxcui: 992447
rxcui: 992438
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI Pharmaceuticals, Inc.a52e210f-b99d-493e-b679-ec565c6ff72d2025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma7a186bcd-ab8c-4695-8289-4cd33bb551cf2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.13d9e59d-eadb-41d5-9f47-9c11a6efb31c2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d545105f-27dc-4820-b0b1-fcf17e0be0f02025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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