Bupropion Hydrochloride

Product NDC
68071-5213
11-digit product format
680715213
Labeler code
68071
Product ID
68071-5213_d7749c32-51c4-95a4-e053-2a95a90a44d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203013
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5213-12022-02-07C16284748780-1d6a99b39-538f-a426-e053-dadaa90af4c2a111c64b-d5a0-a078-e053-2995a90ac649
68071-5213-12022-01-28C16284748780-1d6a99b39-538f-a426-e053-dadaa90af4c2a111c64b-d5a0-a078-e053-2995a90ac649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5213-168071521301100 TABLET, FILM COATED in 1 BOTTLE (68071-5213-1) 2020-03-170000-00-00NoNoCurrent