Hydromorphone Hydrochloride

Product NDC
67296-1414
11-digit product format
672961414
Labeler code
67296
Product ID
67296-1414_b95be7aa-c167-66f1-e053-2995a90a574d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076855
Marketing category
ANDA
Marketing start
2021-01-01
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1414-2Hydromorphone Hydrochloride20 in 1 BOTTLETABLET206
67296-1414-4Hydromorphone Hydrochloride40 in 1 BOTTLETABLET406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1414HYDROMORPHONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]6Legacy NDC, 2 package rows20240808_b95bfd6c-cee5-f57d-e053-2995a90a5ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSNb95bfd6c-cee5-f57d-e053-2995a90a5ce16
897696hydromorphone hydrochloride 2 MG Oral TabletSCDb95bfd6c-cee5-f57d-e053-2995a90a5ce16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1414-26729614140220 TABLET in 1 BOTTLE (67296-1414-2) 20 tablet2021-01-010000-00-00NoNoCurrent
67296-1414-46729614140440 TABLET in 1 BOTTLE (67296-1414-4) 40 tablet2021-01-010000-00-00NoNoCurrent