FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0406-3244
11-digit product format
004063244
Labeler code
0406
Product ID
0406-3244_8c16f6cf-c3d2-458c-9cd1-4fddd7c473a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076855
Marketing category
ANDA
Marketing start
2004-12-23
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
0406-3244-01Hydromorphone Hydrochloride100 in 1 BOTTLETABLET10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-3244-01EA - Each0406-3244ed2c61f3-8c53-49d1-8280-35248b8ef29012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]10
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROMORPHONE HYDROCHLORIDE TABLET [STAT RX USA LLC]2
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROMORPHONEACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-3244HYDROMORPHONE HYDROCHLORIDE TABLET [SPECGX LLC]28Current NDC, Legacy NDC, 1 package rows20250412_4c5c1cc8-c42b-46e3-ad68-8e22f57101f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897702HYDROmorphone HCl 4 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897710HYDROmorphone HCl 8 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897696hydromorphone hydrochloride 2 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897702hydromorphone hydrochloride 4 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897710hydromorphone hydrochloride 8 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897696HYDROmorphone HCl 2 MG Oral TabletPSNe4758743-9b2c-4612-8399-ad2db372e2b76
897702HYDROmorphone HCl 4 MG Oral TabletPSNe4758743-9b2c-4612-8399-ad2db372e2b76
897696hydromorphone hydrochloride 2 MG Oral TabletSCDe4758743-9b2c-4612-8399-ad2db372e2b76
897702hydromorphone hydrochloride 4 MG Oral TabletSCDe4758743-9b2c-4612-8399-ad2db372e2b76
897696HYDROmorphone HCl 2 MG Oral TabletPSNd42f2e61-f65a-42f2-bec5-2d248d788e782
897702HYDROmorphone HCl 4 MG Oral TabletPSNd42f2e61-f65a-42f2-bec5-2d248d788e782
897696hydromorphone hydrochloride 2 MG Oral TabletSCDd42f2e61-f65a-42f2-bec5-2d248d788e782
897702hydromorphone hydrochloride 4 MG Oral TabletSCDd42f2e61-f65a-42f2-bec5-2d248d788e782
897696HYDROmorphone HCl 2 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897702HYDROmorphone HCl 4 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897710HYDROmorphone HCl 8 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897696hydromorphone hydrochloride 2 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301
897702hydromorphone hydrochloride 4 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301
897710hydromorphone hydrochloride 8 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-3244-0100406324401100 TABLET in 1 BOTTLE (0406-3244-01) 100 tablet2004-12-230000-00-00NoNoCurrent