NALTREXONE HYDROCHLORIDE

Product NDC
70518-1312
11-digit product format
705181312
Labeler code
70518
Product ID
70518-1312_b8cffe88-be5b-3bf9-e053-2a95a90a3aa1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076264
Marketing category
ANDA
Marketing start
2018-07-19
Marketing end
0000-00-00
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1312-07051813120030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1312-0) 2018-07-190000-00-00NoNoCurrent