hydromorphone hydrochloride

Product NDC
43602-266
11-digit product format
436020266
Labeler code
43602
Product ID
43602-266_728caa01-5e35-4d0e-b15a-d716cd48c34f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascent Pharmaceuticals, Inc.
Application
ANDA212133
Marketing category
ANDA
Marketing start
2020-09-24
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
No
Listing certified through
2021-12-31
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43602-266HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC.]3Legacy NDC20201016_59b1e29f-3292-422c-bfdc-56803436c0ba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43602-266-0543602026605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-05) 2020-09-240000-00-00NoNoCurrent
43602-266-304360202663030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-266-30) 2020-09-240000-00-00NoNoCurrent