Tramadol Hydrochloride

Product NDC
60429-585
11-digit product format
604290585
Labeler code
60429
Product ID
60429-585_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
300 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
60429-585-30EA - Each60429-585868589d1-7e5b-4310-b57d-3244dcbdcc8912017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-585-306042905853030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-585-30) 2016-10-200000-00-00NoNoCurrent