FDA.reportPublic FDA data

HYDROMORPHONE HYDROCHLORIDE

Product NDC
0574-7224
11-digit product format
005747224
Labeler code
0574
Product ID
0574-7224_8c369b50-cf2a-4e30-a31c-ccf5f49ab920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1996-01-31
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROMORPHONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE3 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897749Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bfbba46-1979-4797-a29e-d67718131686Available 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
0574-7224-06HYDROMORPHONE HYDROCHLORIDE1 in 1 PACKETSUPPOSITORY16
0574-7224-06HYDROMORPHONE HYDROCHLORIDE6 in 1 BOXSUPPOSITORY66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7224-06EA - Each0574-72248b77ad7c-6e22-4230-b332-bdf5fe1be11d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRHYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7224HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [PADAGIS US LLC]6Current NDC, Legacy NDC, 2 package rows20240502_1bfbba46-1979-4797-a29e-d67718131686.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 HYDROCHLORIDEPadagis US LLC1bfbba46-1979-4797-a29e-d677181316862023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0574-7224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897749HYDROmorphone HCl 3 MG Rectal SuppositoryPSNbec32a94-4b79-4bd4-b000-45e9030d3106103
897749hydromorphone hydrochloride 3 MG Rectal SuppositorySCDbec32a94-4b79-4bd4-b000-45e9030d3106103
897749HYDROmorphone HCl 3 MG Rectal SuppositoryPSN1bfbba46-1979-4797-a29e-d677181316866
897749hydromorphone hydrochloride 3 MG Rectal SuppositorySCD1bfbba46-1979-4797-a29e-d677181316866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7224-06005747224066 PACKET in 1 BOX (0574-7224-06) / 1 SUPPOSITORY in 1 PACKET6 packet1996-01-310000-00-00NoNoCurrent