FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
31722-066
11-digit product format
317220066
Labeler code
31722
Product ID
31722-066_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
100 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 HYDROCHLORIDE100 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
31722-066-01Bupropion hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
31722-066-05Bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5003
31722-066-60Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-066BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 3 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 TabletPSN0aa86bd6-b37b-45f7-a837-b067e41184e93
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf69b322b-93ab-407a-bf25-fe13c6896ca63
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa3
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
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD0aa86bd6-b37b-45f7-a837-b067e41184e93
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa3
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 TabletSY30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa3
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY0aa86bd6-b37b-45f7-a837-b067e41184e93
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
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN350336bf-57b1-4d2f-bf25-956bb6023c071
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN38f52cec-9534-dab8-e063-6294a90a07041
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN50afb442-e7c6-d28c-e063-6294a90a2b7e1
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNc5d55b0c-8b81-476a-994e-1989e2a562551
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDc5d55b0c-8b81-476a-994e-1989e2a562551
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD50afb442-e7c6-d28c-e063-6294a90a2b7e1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD38f52cec-9534-dab8-e063-6294a90a07041
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD350336bf-57b1-4d2f-bf25-956bb6023c071
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY50afb442-e7c6-d28c-e063-6294a90a2b7e1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYc5d55b0c-8b81-476a-994e-1989e2a562551
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY350336bf-57b1-4d2f-bf25-956bb6023c071
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY38f52cec-9534-dab8-e063-6294a90a07041
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-066-0131722006601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-066-01) 2023-05-31NoNoHistorical
31722-066-0531722006605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-066-05) 2023-05-31NoNoHistorical
31722-066-603172200666060 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-066-60) 2023-05-31NoNoHistorical