Hydromorphone Hydrochloride

Product NDC
52959-413
11-digit product format
529590413
Labeler code
52959
Product ID
52959-413_0a9c8629-be18-4f5d-8f19-e96b46d63dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077471
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-413-02Hydromorphone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
52959-413-60Hydromorphone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-413HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111209_7c122909-cedb-469a-99de-a44bcd51238d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897702HYDROmorphone HCl 4 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897710HYDROmorphone HCl 8 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897696hydromorphone hydrochloride 2 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897702hydromorphone hydrochloride 4 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897710hydromorphone hydrochloride 8 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-413-0252959041302120 in 1 BOTTLE, PLASTICHistorical
52959-413-605295904136060 in 1 BOTTLE, PLASTICHistorical