FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
63323-854
11-digit product format
633230854
Labeler code
63323
Product ID
63323-854_9e8522c6-595c-46f9-bb25-272aa4683e0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA019034
Marketing category
NDA
Marketing start
2017-12-15
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897653, 897753, 1724276, 1724338, 1724340, 1724341

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
63323-854-03Hydromorphone Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-854-10Hydromorphone Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-854-03ML - Milliliter63323-8542ca24287-6179-4fa7-97df-32ad4913087c12018-07-03
63323-854-10ML - Milliliter63323-854f0e85538-c6ca-4b21-8f0d-b699226e2aff12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-854HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250418_e034eb96-03e0-46e1-8b92-5e1f94555e7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897653HYDROmorphone HCl 1 MG in 1 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724338HYDROmorphone HCl 10 MG in 1 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724276HYDROmorphone HCl 2 MG in 1 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
897753HYDROmorphone HCl 4 MG in 1 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724340HYDROmorphone HCl 50 MG in 5 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724341HYDROmorphone HCl 500 MG in 50 ML InjectionPSNe034eb96-03e0-46e1-8b92-5e1f94555e7b6
8976531 ML hydromorphone hydrochloride 1 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
17243381 ML hydromorphone hydrochloride 10 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
17242761 ML hydromorphone hydrochloride 2 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
8977531 ML hydromorphone hydrochloride 4 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
17243405 ML hydromorphone hydrochloride 10 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
172434150 ML hydromorphone hydrochloride 10 MG/ML InjectionSCDe034eb96-03e0-46e1-8b92-5e1f94555e7b6
897653hydromorphone HCl 1 MG per 1 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724338hydromorphone HCl 10 MG per 1 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724276hydromorphone HCl 2 MG per 1 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6
897753hydromorphone HCl 4 MG per 1 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724340hydromorphone HCl 50 MG per 5 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6
1724341hydromorphone HCl 500 MG per 50 ML InjectionSYe034eb96-03e0-46e1-8b92-5e1f94555e7b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-854-03633230854031 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-854-106332308541025 VIAL, SINGLE-DOSE in 1 CARTON (63323-854-10) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-854-03) 2017-12-150000-00-00NoNoCurrent