Tramadol Hydrochloride

Product NDC
60429-583
11-digit product format
604290583
Labeler code
60429
Product ID
60429-583_d44e9782-c3fe-988b-e053-2a95a90a1a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride extended-release tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA200491
Marketing category
ANDA
Marketing start
2012-06-27
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-583-30EA - Each60429-583e7d7834a-8bea-4055-a2a6-bb2f2539ef3412017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-583-306042905833030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-583-30) 2016-10-200000-00-00NoNoCurrent