FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
31722-068
11-digit product format
317220068
Labeler code
31722
Product ID
31722-068_4daf04dc-4a68-9ce5-e063-6294a90a7033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216800
Marketing category
ANDA
Marketing start
2023-05-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

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
31722-068-01Bupropion hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
31722-068-05Bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5003
31722-068-60Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE603
31722-068-90Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-068BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250202_f69b322b-93ab-407a-bf25-fe13c6896ca6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf69b322b-93ab-407a-bf25-fe13c6896ca63
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf69b322b-93ab-407a-bf25-fe13c6896ca63
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNf69b322b-93ab-407a-bf25-fe13c6896ca63
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDf69b322b-93ab-407a-bf25-fe13c6896ca63
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf69b322b-93ab-407a-bf25-fe13c6896ca63
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDf69b322b-93ab-407a-bf25-fe13c6896ca63
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYf69b322b-93ab-407a-bf25-fe13c6896ca63
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf69b322b-93ab-407a-bf25-fe13c6896ca63
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYf69b322b-93ab-407a-bf25-fe13c6896ca63
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN5c111cf0-0199-4a4d-8138-81579af4c14d2
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD5c111cf0-0199-4a4d-8138-81579af4c14d2
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY5c111cf0-0199-4a4d-8138-81579af4c14d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-068-0131722006801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-01) 2023-05-31NoNoHistorical
31722-068-0531722006805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-05) 2023-05-31NoNoHistorical
31722-068-603172200686060 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-60) 2023-05-31NoNoHistorical
31722-068-903172200689090 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-068-90) 2023-05-31NoNoHistorical