Tramadol Hydrochloride

Product NDC
70518-0054
11-digit product format
705180054
Labeler code
70518
Product ID
70518-0054_8011e60f-8687-3b68-e053-2a91aa0a0913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076003
Marketing category
ANDA
Marketing start
2016-12-12
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