FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
42858-304
11-digit product format
428580304
Labeler code
42858
Product ID
42858-304_b786b01b-46f9-4a00-a667-699e813a741b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
NDA019891
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-07-20
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
5 mg/5mL
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 HYDROCHLORIDE5 mg/5mL

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
42858-304-16Hydromorphone Hydrochloride473 mL in 1 BOTTLE, PLASTICSOLUTION47320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-304-16ML - Milliliter42858-30464ad2769-3771-4109-9e03-5463592d661312013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-304HYDROMORPHONE 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
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSNfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCDfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSYfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSYfab97112-e276-40e0-bc82-0a29d7fa75fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-304-1642858030416473 mL in 1 BOTTLE, PLASTIC (42858-304-16) 473 ml2012-07-200000-00-00NoNoCurrent