tramadol hydrochloride

Product NDC
63629-4394
11-digit product format
636294394
Labeler code
63629
Product ID
63629-4394_d15a592c-d02b-5bf9-11bb-005141ce5472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4394-12020-06-14C16284748780-19d75b9d0-567d-f424-e053-dadaa90a57ced15a592c-d02b-5bf9-11bb-005141ce5472
63629-4394-12020-01-31C16284748780-19d75b9d0-567d-f424-e053-dadaa90a57ced15a592c-d02b-5bf9-11bb-005141ce5472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4394-163629439401112 TABLET in 1 BOTTLE (63629-4394-1) 112 tablet2005-03-290000-00-00NoNoCurrent