FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0054-0386
11-digit product format
000540386
Labeler code
0054
Product ID
0054-0386_4c3c8198-731d-4136-9222-01063f3364cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074653
Marketing category
ANDA
Marketing start
2012-03-01
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897657, 897702, 897710

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0386-63Hydromorphone Hydrochloride473 mL in 1 BOTTLESOLUTION47320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0386-63ML - Milliliter0054-03863f2e7982-40a6-4b0d-a463-48b78fc8556612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
RASPBERRYINACTIVE INGREDIENT4N14V5R27WHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9
WATERINACTIVE INGREDIENT059QF0KO0RHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0386HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 1 package rows20240308_cc574063-6ede-4da7-82c4-7450c92b229b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSNcc574063-6ede-4da7-82c4-7450c92b229b20
897702HYDROmorphone HCl 4 MG Oral TabletPSNcc574063-6ede-4da7-82c4-7450c92b229b20
897710HYDROmorphone HCl 8 MG Oral TabletPSNcc574063-6ede-4da7-82c4-7450c92b229b20
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCDcc574063-6ede-4da7-82c4-7450c92b229b20
897702hydromorphone hydrochloride 4 MG Oral TabletSCDcc574063-6ede-4da7-82c4-7450c92b229b20
897710hydromorphone hydrochloride 8 MG Oral TabletSCDcc574063-6ede-4da7-82c4-7450c92b229b20
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSYcc574063-6ede-4da7-82c4-7450c92b229b20
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSYcc574063-6ede-4da7-82c4-7450c92b229b20
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSN2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCD2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSY2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSY2f1449bd-2b80-4383-9336-df9940e87a504
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSN65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCD65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSY65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSY65c27d6d-43ab-22ce-e053-2991aa0a51642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0386-6300054038663473 mL in 1 BOTTLE (0054-0386-63) 473 ml2012-03-010000-00-00NoNoCurrent