FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0641-2341
11-digit product format
006412341
Labeler code
0641
Product ID
0641-2341_29e3211f-1115-45e9-8416-c3dfe01a9916
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L960UP2KRWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897745Internal RxNorm lookup
1724276Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b325028e-0722-4c8c-9fdb-ab6fb0dc460cAvailable on FDA.report

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
0641-2341-39Hydromorphone Hydrochloride20 mL in 1 VIALINJECTION209
0641-2341-41Hydromorphone Hydrochloride20 in 1 CARTONINJECTION209

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

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

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 (product): 0641-2341

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
0641-2341-390064123413920 mL in 1 VIAL20 mlHistorical
0641-2341-410064123414120 VIAL in 1 CARTON (0641-2341-41) / 20 mL in 1 VIAL (0641-2341-39) 20 vial1972-01-010000-00-00NoNoCurrent