FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
31722-487
11-digit product format
317220487
Labeler code
31722
Product ID
31722-487_500b524c-53eb-26fe-e063-6394a90a8da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217898
Marketing category
ANDA
Marketing start
2025-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-487-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
31722-487-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
31722-487-90BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNc71f18b7-36a3-4489-96b4-e8fbec4f73a12
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc71f18b7-36a3-4489-96b4-e8fbec4f73a12
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYc71f18b7-36a3-4489-96b4-e8fbec4f73a12
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYc71f18b7-36a3-4489-96b4-e8fbec4f73a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-487-0531722048705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-487-05) 2025-10-01NoNoCurrent
31722-487-303172204873030 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-487-30) 2025-10-01NoNoCurrent
31722-487-903172204879090 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-487-90) 2025-10-01NoNoCurrent