FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
42858-303
11-digit product format
428580303
Labeler code
42858
Product ID
42858-303_b786b01b-46f9-4a00-a667-699e813a741b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 mg/1
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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897657, 897696, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42858-303-01Hydromorphone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-303-01EA - Each42858-3036732a978-5a0c-4eee-aa74-7dc3954ab6f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
WATERINACTIVE INGREDIENT059QF0KO0RHYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]10
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-303HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.]16Current NDC, Legacy NDC, 1 package rows20240119_37565441-0d95-4743-a695-d7b3326f58a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSN37565441-0d95-4743-a695-d7b3326f58a120
897696HYDROmorphone HCl 2 MG Oral TabletPSN37565441-0d95-4743-a695-d7b3326f58a120
897702HYDROmorphone HCl 4 MG Oral TabletPSN37565441-0d95-4743-a695-d7b3326f58a120
897710HYDROmorphone HCl 8 MG Oral TabletPSN37565441-0d95-4743-a695-d7b3326f58a120
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCD37565441-0d95-4743-a695-d7b3326f58a120
897696hydromorphone hydrochloride 2 MG Oral TabletSCD37565441-0d95-4743-a695-d7b3326f58a120
897702hydromorphone hydrochloride 4 MG Oral TabletSCD37565441-0d95-4743-a695-d7b3326f58a120
897710hydromorphone hydrochloride 8 MG Oral TabletSCD37565441-0d95-4743-a695-d7b3326f58a120
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSY37565441-0d95-4743-a695-d7b3326f58a120
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSY37565441-0d95-4743-a695-d7b3326f58a120
897696HYDROmorphone HCl 2 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897702HYDROmorphone HCl 4 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897710HYDROmorphone HCl 8 MG Oral TabletPSN86638efd-9eb9-440e-b48b-b1bd52ccbc611
897710HYDROmorphone HCl 8 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897696hydromorphone hydrochloride 2 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1
897702hydromorphone hydrochloride 4 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1
897710hydromorphone hydrochloride 8 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1
897710hydromorphone hydrochloride 8 MG Oral TabletSCD86638efd-9eb9-440e-b48b-b1bd52ccbc611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-303-0142858030301100 TABLET in 1 BOTTLE, PLASTIC (42858-303-01) 100 tablet2009-11-230000-00-00NoNoCurrent