TRAMADOL HYDROCHLORIDE

Product NDC
71205-389
11-digit product format
712050389
Labeler code
71205
Product ID
71205-389_2dcb6956-3e29-498b-9a87-ccfe08f2a0fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091498
Marketing category
ANDA
Marketing start
2015-05-22
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
71205-389TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]4Legacy NDC20201229_5e15e8c5-b5d0-4945-a717-df3907266343.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-389-157120503891515 TABLET, FILM COATED in 1 BOTTLE (71205-389-15) 2020-12-160000-00-00NoNoCurrent
71205-389-207120503892020 TABLET, FILM COATED in 1 BOTTLE (71205-389-20) 2020-01-170000-00-00NoNoCurrent
71205-389-307120503893030 TABLET, FILM COATED in 1 BOTTLE (71205-389-30) 2020-01-170000-00-00NoNoCurrent
71205-389-607120503896060 TABLET, FILM COATED in 1 BOTTLE (71205-389-60) 2020-01-170000-00-00NoNoCurrent
71205-389-7271205038972120 TABLET, FILM COATED in 1 BOTTLE (71205-389-72) 2020-01-210000-00-00NoNoCurrent
71205-389-7871205038978180 TABLET, FILM COATED in 1 BOTTLE (71205-389-78) 2020-11-110000-00-00NoNoCurrent
71205-389-907120503899090 TABLET, FILM COATED in 1 BOTTLE (71205-389-90) 2020-01-170000-00-00NoNoCurrent