Naltrexone Hydrochloride

Product NDC
63629-1046
11-digit product format
636291046
Labeler code
63629
Product ID
63629-1046_3db463fe-f016-468f-8dda-878bbbb80733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naltrexone Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075274
Marketing category
ANDA
Marketing start
2013-09-23
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1046-1EA - Each63629-10464d018d89-e88c-4f82-9e0a-050a3741e2bb12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1046NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]6Legacy NDC20230127_94c3e2de-36e4-42d4-b6e8-53b4aff1c4ed.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1046-16362910460130 TABLET, FILM COATED in 1 BOTTLE (63629-1046-1) 2019-07-010000-00-00NoNoCurrent