FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
0641-6169
11-digit product format
006416169
Labeler code
0641
Product ID
0641-6169_08fdd324-f2ce-4a29-a6d1-fc88aa10b7ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA216899
Marketing category
ANDA
Marketing start
2024-04-26
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897756, 897757, 1433251, 2277368

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6169-01Hydromorphone Hydrochloride1 mL in 1 SYRINGEINJECTION13
0641-6169-10Hydromorphone Hydrochloride10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6169-01ML - Milliliter0641-6169a82f4785-242d-4b0f-b5c1-0ea32f41504112024-06-10
0641-6169-10ML - Milliliter0641-6169eff788d7-dd5c-4bac-952d-bc62d90ad80912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6169HYDROMORPHONE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20240509_31d5a37a-0e90-4e88-be14-75c877be9de2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1433251HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled SyringePSN31d5a37a-0e90-4e88-be14-75c877be9de23
897756HYDROmorphone HCl 1 MG in 1 ML Prefilled SyringePSN31d5a37a-0e90-4e88-be14-75c877be9de23
897757HYDROmorphone HCl 2 MG in 1 ML Prefilled SyringePSN31d5a37a-0e90-4e88-be14-75c877be9de23
2277368HYDROmorphone hydrochloride 0.2 MG in 1 mL Prefilled SyringePSN31d5a37a-0e90-4e88-be14-75c877be9de23
14332510.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCD31d5a37a-0e90-4e88-be14-75c877be9de23
22773681 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled SyringeSCD31d5a37a-0e90-4e88-be14-75c877be9de23
8977561 ML hydromorphone hydrochloride 1 MG/ML Prefilled SyringeSCD31d5a37a-0e90-4e88-be14-75c877be9de23
8977571 ML hydromorphone hydrochloride 2 MG/ML Prefilled SyringeSCD31d5a37a-0e90-4e88-be14-75c877be9de23
1433251hydromorphone HCl 0.5 MG per 0.5 ML Prefilled SyringeSY31d5a37a-0e90-4e88-be14-75c877be9de23
897756hydromorphone HCl 1 MG per 1 ML Prefilled SyringeSY31d5a37a-0e90-4e88-be14-75c877be9de23
897757hydromorphone HCl 2 MG per 1 ML Prefilled SyringeSY31d5a37a-0e90-4e88-be14-75c877be9de23
2277368hydromorphone hydrochloride 0.2 MG per 1 ML Prefilled SyringeSY31d5a37a-0e90-4e88-be14-75c877be9de23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6169-01006416169011 mL in 1 SYRINGE1 mlHistorical
0641-6169-100064161691010 SYRINGE in 1 CARTON (0641-6169-10) / 1 mL in 1 SYRINGE (0641-6169-01) 10 syringe2024-04-26NoNoHistorical