tramadol hydrochloride

Product NDC
58118-0377
11-digit product format
581180377
Labeler code
58118
Product ID
58118-0377_ab5e1b81-7b29-22ab-e053-2a95a90a3b54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0377TRAMADOL HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20240110_88e66c0e-22a0-4ca7-bbff-c2f63df57c96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0377-85811803770830 TABLET in 1 BLISTER PACK (58118-0377-8) 30 tablet2020-05-260000-00-00NoNoCurrent