Bupropion Hydrochloride

Product NDC
69097-071
11-digit product format
690970071
Labeler code
69097
Product ID
69097-071_9c292b5a-2a09-4f01-b1fe-8652dd577542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA., Inc.
Application
ANDA207479
Marketing category
ANDA
Marketing start
2023-10-25
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
ZG7E5POY8OBUPROPION HYDROCHLORIDE31677-93-7BUPROPION HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-071-1269097007112500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-071-12) 2023-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion HydrochlorideA-S Medication Solutions2025-10-16HUMAN PRESCRIPTION DRUG LABEL1
Bupropion HydrochlorideA-S Medication Solutions2025-10-16HUMAN PRESCRIPTION DRUG LABEL1
Bupropion HydrochlorideCipla USA., Inc. | ScieGen pharmaceuticals,Inc2023-10-19HUMAN PRESCRIPTION DRUG LABEL1