QDOLO

Product NDC
71511-301
11-digit product format
715110301
Labeler code
71511
Product ID
71511-301_ee03388d-3681-a3be-e053-2995a90ae26b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Athena Bioscience, LLC
Application
NDA214044
Marketing category
NDA
Marketing start
2020-09-11
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
5 mg/mL
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
71511-301-1671511030116473 mL in 1 BOTTLE (71511-301-16) 473 ml2020-09-110000-00-00NoNoCurrent