TRAMADOL HYDROCHLORIDE

Product NDC
35356-790
11-digit product format
353560790
Labeler code
35356
Product ID
35356-790_0a9759ab-0b91-4337-a85d-418c266a84c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35356-790-303535607903030 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-790-30) 2011-12-120000-00-00NoNoCurrent