FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0641-0121
Requested package NDC
0641-0121-25
11-digit product format
006410121
Labeler code
0641
Product ID
0641-0121_b58ab10f-f9d0-4cea-966d-9fe9acf49b03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1972-01-01
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0641-01210641-0121-25DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-0121-21Hydromorphone Hydrochloride1 mL in 1 VIALINJECTION19
0641-0121-25Hydromorphone Hydrochloride25 in 1 CARTONINJECTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0121-21ML - Milliliter0641-0121a50fa085-0e05-4962-b5d7-c99363dc8e0f12012-07-24
0641-0121-25ML - Milliliter0641-0121fc1ecab4-5b73-4f0c-9061-85ac04bc3bd412012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0121HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Legacy NDC, 2 package rows20240410_b325028e-0722-4c8c-9fdb-ab6fb0dc460c.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 0641-0121-25
ndc (product): 0641-0121
ndc11 (package): 00641012125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724276HYDROmorphone HCl 2 MG in 1 ML InjectionPSNb325028e-0722-4c8c-9fdb-ab6fb0dc460c9
897745HYDROmorphone HCl 2 MG/ML Injectable SolutionPSNb325028e-0722-4c8c-9fdb-ab6fb0dc460c9
17242761 ML hydromorphone hydrochloride 2 MG/ML InjectionSCDb325028e-0722-4c8c-9fdb-ab6fb0dc460c9
897745hydromorphone hydrochloride 2 MG/ML Injectable SolutionSCDb325028e-0722-4c8c-9fdb-ab6fb0dc460c9
1724276hydromorphone HCl 2 MG per 1 ML InjectionSYb325028e-0722-4c8c-9fdb-ab6fb0dc460c9
897745hydromorphone HCl 2 MG/ML Injectable SolutionSYb325028e-0722-4c8c-9fdb-ab6fb0dc460c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0121-250064101212525 VIAL in 1 CARTON (0641-0121-25) > 1 mL in 1 VIAL (0641-0121-21) 25 vial1972-01-010000-00-00NoNoCurrent