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 Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897749

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

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