Hydromorphone Hydrochloride

Product NDC
67296-1642
11-digit product format
672961642
Labeler code
67296
Product ID
67296-1642_b8df8208-820e-72a9-e053-2a95a90ae5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077471
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1642-92023-01-30C16284748780-1f386c64a-1f89-0266-e053-dadaa90a7c1aHydromorphone 2mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1642-9Hydromorphone Hydrochloride24 in 1 BOTTLETABLET2410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1642HYDROMORPHONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]10Legacy NDC, 1 package rows20210115_88dfac9a-c7ad-01be-e053-2995a90a6d40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN88dfac9a-c7ad-01be-e053-2995a90a6d4010
897696hydromorphone hydrochloride 2 MG Oral TabletSCD88dfac9a-c7ad-01be-e053-2995a90a6d4010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1642-96729616420924 TABLET in 1 BOTTLE (67296-1642-9) 24 tablet2019-01-010000-00-00NoNoCurrent