FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
60687-566
11-digit product format
606870566
Labeler code
60687
Product ID
60687-566_51a03444-b8e6-9dca-e063-6394a90aba7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
NDA019891
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-09-01
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897657

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
60687-566-40Hydromorphone Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION54
60687-566-46Hydromorphone Hydrochloride10 in 1 TRAYSOLUTION104
60687-566-86Hydromorphone Hydrochloride3 in 1 CASESOLUTION34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-566-40ML - Milliliter60687-566897667c7-ebbe-4469-9b67-e41605ea751c12021-10-08
60687-566-46ML - Milliliter60687-566d3a28f33-a2f6-4d19-aaf9-4c0c3336a3a412021-10-08
60687-566-86ML - Milliliter60687-5664d4e0ecc-472c-4fdb-8448-986b1e95da3d12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-566HYDROMORPHONE HYDROCHLORIDE SOLUTION [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 3 package rows20240622_fab97112-e276-40e0-bc82-0a29d7fa75fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSNfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCDfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSYfab97112-e276-40e0-bc82-0a29d7fa75fa4
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSYfab97112-e276-40e0-bc82-0a29d7fa75fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-566-40606870566405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-566-466068705664610 in 1 TRAYHistorical
60687-566-86606870566863 TRAY in 1 CASE (60687-566-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-566-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-566-40) 3 tray2021-09-300000-00-00NoNoCurrent