FDA.reportPublic FDA data

NDC 0641-2341-39 - 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
0641-2341
Requested NDC
0641-2341-39
Package NDCs from labels
0641-2341-39, 0641-2341-41
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYDROMORPHONE HYDROCHLORIDE INJECTION, USP CII Rx onlyHikma Pharmaceuticals USA Inc.2026-03-02HUMAN 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
0641-2341-39Hydromorphone Hydrochloride20 mL in 1 VIALINJECTION209
0641-2341-41Hydromorphone Hydrochloride20 in 1 CARTONINJECTION209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-2341HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20240410_b325028e-0722-4c8c-9fdb-ab6fb0dc460c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-2341-39ML - Milliliter0641-234107c73fed-509b-4689-b3d9-b97c394df8a312012-07-24
0641-2341-41ML - Milliliter0641-2341f8f730cd-1fe9-4858-9941-4452c576a36912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RHYDROMORPHONE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5

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 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 0641-0121-21
ndc (package): 0641-2341-41
ndc (package): 0641-0121-25
ndc (package): 0641-2341-39
ndc (product): 0641-2341
ndc (product): 0641-0121
ndc11 (package): 00641234139
rxcui: 897745
rxcui: 1724276
spl id: 29e3211f-1115-45e9-8416-c3dfe01a9916
spl set id: b325028e-0722-4c8c-9fdb-ab6fb0dc460c
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cc574063-6ede-4da7-82c4-7450c92b229b2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.f9ca2ef5-46d8-475a-a26e-f7c8becd6db72026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L960UP2KRW
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.c729424e-e483-4bf8-b86c-ce56636dcffa2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 897745
unii: L960UP2KRW

Reported adverse events (FAERS/openFDA)#

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