FDA.reportPublic FDA data

HYDROMORPHONE HYDROCHLORIDE

Product NDC
13107-109
11-digit product format
131070109
Labeler code
13107
Product ID
13107-109_1c45740c-5fb6-4cf7-81b9-0865717334e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA205814
Marketing category
ANDA
Marketing start
2016-05-17
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 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
13107-109-01HYDROMORPHONE HYDROCHLORIDE100 in 1 BOTTLETABLET1007
13107-109-05HYDROMORPHONE HYDROCHLORIDE500 in 1 BOTTLETABLET5007
13107-109-20HYDROMORPHONE HYDROCHLORIDE20 in 1 BOTTLETABLET207
13107-109-99HYDROMORPHONE HYDROCHLORIDE1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-109-01EA - Each13107-1099a18b5a6-203a-4835-9fd6-82b484156e2612016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-109HYDROMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]7Current NDC, Legacy NDC, 4 package rows20240706_f778dfab-e109-428e-b1b7-4dfb1b8293e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSNf778dfab-e109-428e-b1b7-4dfb1b8293e47
897702HYDROmorphone HCl 4 MG Oral TabletPSNf778dfab-e109-428e-b1b7-4dfb1b8293e47
897710HYDROmorphone HCl 8 MG Oral TabletPSNf778dfab-e109-428e-b1b7-4dfb1b8293e47
897696hydromorphone hydrochloride 2 MG Oral TabletSCDf778dfab-e109-428e-b1b7-4dfb1b8293e47
897702hydromorphone hydrochloride 4 MG Oral TabletSCDf778dfab-e109-428e-b1b7-4dfb1b8293e47
897710hydromorphone hydrochloride 8 MG Oral TabletSCDf778dfab-e109-428e-b1b7-4dfb1b8293e47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-109-0113107010901100 TABLET in 1 BOTTLE (13107-109-01) 100 tablet2016-05-170000-00-00NoNoCurrent
13107-109-0513107010905500 TABLET in 1 BOTTLE (13107-109-05) 500 tablet2016-05-170000-00-00NoNoCurrent
13107-109-201310701092020 TABLET in 1 BOTTLE (13107-109-20) 20 tablet2016-05-170000-00-00NoNoCurrent
13107-109-99131070109991000 TABLET in 1 BOTTLE (13107-109-99) 1000 tablet2016-05-170000-00-00NoNoCurrent