FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
87063-038
11-digit product format
870630038
Labeler code
87063
Product ID
87063-038_451ccd08-4749-97a1-e063-6294a90ac5ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
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
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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897696, 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
87063-038-01Hydromorphone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1001
87063-038-05Hydromorphone Hydrochloride5 in 1 BOTTLE, PLASTICTABLET51
87063-038-07Hydromorphone Hydrochloride7 in 1 BOTTLE, PLASTICTABLET71
87063-038-10Hydromorphone Hydrochloride10 in 1 BOTTLE, PLASTICTABLET101
87063-038-14Hydromorphone Hydrochloride14 in 1 BOTTLE, PLASTICTABLET141
87063-038-20Hydromorphone Hydrochloride20 in 1 BOTTLE, PLASTICTABLET201
87063-038-30Hydromorphone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301
87063-038-50Hydromorphone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5001
87063-038-60Hydromorphone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
87063-038-90Hydromorphone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-038-0187063003801100 TABLET in 1 BOTTLE, PLASTIC (87063-038-01) 100 tablet2025-12-04NoNoCurrent
87063-038-05870630038055 TABLET in 1 BOTTLE, PLASTIC (87063-038-05) 5 tablet2025-12-04NoNoCurrent
87063-038-07870630038077 TABLET in 1 BOTTLE, PLASTIC (87063-038-07) 7 tablet2025-12-04NoNoCurrent
87063-038-108706300381010 TABLET in 1 BOTTLE, PLASTIC (87063-038-10) 10 tablet2025-12-04NoNoCurrent
87063-038-148706300381414 TABLET in 1 BOTTLE, PLASTIC (87063-038-14) 14 tablet2025-12-04NoNoCurrent
87063-038-208706300382020 TABLET in 1 BOTTLE, PLASTIC (87063-038-20) 20 tablet2025-12-04NoNoCurrent
87063-038-308706300383030 TABLET in 1 BOTTLE, PLASTIC (87063-038-30) 30 tablet2025-12-04NoNoCurrent
87063-038-5087063003850500 TABLET in 1 BOTTLE, PLASTIC (87063-038-50) 500 tablet2025-12-03NoNoCurrent
87063-038-608706300386060 TABLET in 1 BOTTLE, PLASTIC (87063-038-60) 60 tablet2025-12-04NoNoCurrent
87063-038-908706300389090 TABLET in 1 BOTTLE, PLASTIC (87063-038-90) 90 tablet2025-12-04NoNoCurrent