TRAMADOL HYDROCHLORIDE

Product NDC
0904-6365
11-digit product format
009046365
Labeler code
0904
Product ID
0904-6365_0a531cd7-2dac-49cb-b055-1f828e4d0c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090404
Marketing category
ANDA
Marketing start
2014-02-26
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6365-61EA - Each0904-636567b5c39e-24a2-438c-affe-1f37b248421112014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6365-6100904636561100 BLISTER PACK in 1 CARTON (0904-6365-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2014-02-260000-00-00NoNoCurrent