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 7 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LP29a8b172-1bad-40db-8d73-1fe7fb309cff2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
42657c7a-4d85-4e76-a079-7c2c3c1da359b29ee375-0846-430c-8dc4-0315d1ac40aa2020-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b29ee375-0846-430c-8dc4-0315d1ac40aa
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP08bf9fbf-cc21-41a0-9e81-ec498aa641702019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 992447
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEActavis Pharma, Inc.a32255f0-0077-489e-bdc6-869aca8cd4342016-12-01Warnings, Adverse reactionsExact identifier
rxcui: 992475
rxcui: 992447
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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