Tramadol Hydrochloride

Product NDC
70518-3586
11-digit product format
705183586
Labeler code
70518
Product ID
70518-3586_ef1a50cb-a1a3-2602-e053-2a95a90a0e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203494
Marketing category
ANDA
Marketing start
2022-12-05
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3586TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]8Legacy NDC20241011_417959a7-8560-4949-a34a-4a269c83f932.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3586-07051835860090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3586-0) 2022-12-050000-00-00NoNoCurrent