FDA.reportPublic FDA data

NDC 68084-472-11 - HYDROmorphone 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
68084-472
Requested NDC
68084-472-11
Package NDCs from labels
68084-472-11, 68084-472-01
Manufacturer
American Health Packaging
Effective date
2021-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROmorphone Hydrochloride - American Health PackagingAmerican Health Packaging2021-04-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-472-01EA - Each68084-4727a8d7654-70c9-46a9-a465-3f8aa3fb095c12012-07-24
68084-472-11EA - Each68084-472c9d9bb0c-6462-4258-918d-fa5783abf87912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETrigen Laboratories, LLC8bb81796-6990-40e9-bee4-1f292f91ae992025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEPadagis US LLC780a2616-0392-4715-bc50-71799bea19572025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEASCLEMED USA INC.18f6f54e-1537-4181-9d07-54ddf881a9ee2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c33e6320-4206-4b69-8cac-ebfc2351b8f22025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Inc4de15afe-d676-4faa-a34d-9b9cb20dbf542024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack29765ff0-3b1d-47da-953e-28bf0e6a56ef2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.90bda45c-9dbe-4ed5-91d0-df8446ad70262024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackbec32a94-4b79-4bd4-b000-45e9030d31062024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEAurolife Pharma, LLCf778dfab-e109-428e-b1b7-4dfb1b8293e42023-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEPadagis US LLC1bfbba46-1979-4797-a29e-d677181316862023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
bfee4ad5-5e27-841c-e053-2a95a90a93df8930c2ef-7c1a-4d6e-b44b-ed91d0686d372021-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: bfee4ad5-5e27-841c-e053-2a95a90a93df
spl set id: 8930c2ef-7c1a-4d6e-b44b-ed91d0686d37
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAscent Pharmaceuticals Ince8fd7b0e-22b9-4f8a-8eb2-41d5031779af2017-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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