FDA.reportPublic FDA data

Dilaudid

Product NDC
42858-234
11-digit product format
428580234
Labeler code
42858
Product ID
42858-234_3348b431-907c-4f1d-8a18-e4be2a04df23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
NDA019892
Marketing category
NDA
Marketing start
2017-05-15
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 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
Dilaudid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897657, 897658, 897696, 897698, 897702, 897704, 897710, 897712

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
42858-234-01Dilaudid100 in 1 BOTTLE, PLASTICTABLET10012
42858-234-50Dilaudid500 in 1 BOTTLE, PLASTICTABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-234-01EA - Each42858-234f8c9cf97-8815-41c4-9895-b0ae29d0c42812017-06-15
42858-234-50EA - Each42858-2345f54d171-f699-45fc-9346-2301967b046212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-234DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET DILAUDID (HYDROMORPHONE HYDROCHLORIDE) SOLUTION [RHODES PHARMACEUTICALS L.P.]9Current NDC, Legacy NDC, 2 package rows20240110_d6b40e39-a57e-402c-b4f6-7041e832f837.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897658Dilaudid 1 MG in 1 mL Oral SolutionPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897698DILAUDID 2 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897704DILAUDID 4 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897712DILAUDID 8 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897696HYDROmorphone HCl 2 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897702HYDROmorphone HCl 4 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897710HYDROmorphone HCl 8 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897658hydromorphone hydrochloride 1 MG/ML Oral Solution [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897698hydromorphone hydrochloride 2 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897704hydromorphone hydrochloride 4 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897712hydromorphone hydrochloride 8 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897696hydromorphone hydrochloride 2 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897702hydromorphone hydrochloride 4 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897710hydromorphone hydrochloride 8 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897658Dilaudid 1 MG per 1 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897658Dilaudid 1 MG/ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897698Dilaudid 2 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897704Dilaudid 4 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897712Dilaudid 8 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-234-0142858023401100 TABLET in 1 BOTTLE, PLASTIC (42858-234-01) 100 tablet2017-05-150000-00-00NoNoCurrent
42858-234-25428580234254 BLISTER PACK in 1 CARTON (42858-234-25) > 25 TABLET in 1 BLISTER PACK4 blister pack2017-05-150000-00-00NoNoCurrent
42858-234-5042858023450500 TABLET in 1 BOTTLE, PLASTIC (42858-234-50) 500 tablet2017-05-150000-00-00NoNoCurrent