tramadol hydrochloride

Product NDC
70518-0891
11-digit product format
705180891
Labeler code
70518
Product ID
70518-0891_d8b20a66-a076-3e7d-e053-2995a90aa41c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075964
Marketing category
ANDA
Marketing start
2017-12-12
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0891-07051808910030 TABLET in 1 BOTTLE, PLASTIC (70518-0891-0) 30 tablet2017-12-120000-00-00NoNoCurrent
70518-0891-370518089103120 TABLET in 1 BOTTLE, PLASTIC (70518-0891-3) 120 tablet2020-03-090000-00-00NoNoCurrent