Hydromorphone Hydrochloride

Product NDC
17856-0386
11-digit product format
178560386
Labeler code
17856
Product ID
17856-0386_88cc7d59-5e6c-4f9c-af6b-a4426ba248ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA074653
Marketing category
ANDA
Marketing start
2012-03-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0386-12024-05-15C16284748780-19d75b9d0-d51f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
17856-0386-12024-01-30C16284748780-19d75b9d0-d51f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
17856-0386-12022-09-22C16284748780-19d75b9d0-d51f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984
17856-0386-12020-01-31C16284748780-19d75b9d0-d51f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION. HYDROMORPHONE HYDROCHLORIDE tablets and HYDROMORPHONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0386-1Hydromorphone Hydrochloride72 in 1 CASESOLUTION724
17856-0386-2Hydromorphone Hydrochloride5 mL in 1 CUPSOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0386-1ML - Milliliter17856-0386a3ac3443-c4ca-4c6c-88fb-94d670d967c712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0386HYDROMORPHONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 2 package rows20240517_2f1449bd-2b80-4383-9336-df9940e87a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSN2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCD2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSY2f1449bd-2b80-4383-9336-df9940e87a504
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSY2f1449bd-2b80-4383-9336-df9940e87a504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0386-11785603860172 CUP in 1 CASE (17856-0386-1) > 5 mL in 1 CUP (17856-0386-2) 72 cup2022-09-220000-00-00NoNoCurrent
17856-0386-2178560386025 mL in 1 CUP5 mlHistorical