Bupropion Hydrochloride

Product NDC
68788-7863
11-digit product format
687887863
Labeler code
68788
Product ID
68788-7863_1ca3b0e4-bdae-408e-8a39-4e43252d6111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210081
Marketing category
ANDA
Marketing start
2021-02-08
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7863-1EA - Each68788-786380410f0a-5d31-43aa-9e5d-2fa2f2595c5e12021-03-02
68788-7863-3EA - Each68788-7863accb1c52-6ec6-4873-bc1f-32b818fa2d0b12021-03-02
68788-7863-6EA - Each68788-786393f90be0-400a-401d-b197-a0665cc881f812021-03-02
68788-7863-8EA - Each68788-78631ab2cb4a-ee19-431c-8768-72e4eca96e1012021-03-02
68788-7863-9EA - Each68788-7863c2c76878-f13c-4905-ba3d-cbfe30423c4812021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7863-168788786301100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-1) 2021-02-080000-00-00NoNoCurrent
68788-7863-36878878630330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-3) 2021-02-080000-00-00NoNoCurrent
68788-7863-66878878630660 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-6) 2021-02-080000-00-00NoNoCurrent
68788-7863-868788786308120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-8) 2021-02-080000-00-00NoNoCurrent
68788-7863-96878878630990 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7863-9) 2021-02-080000-00-00NoNoCurrent