FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
68788-8769
11-digit product format
687888769
Labeler code
68788
Product ID
68788-8769_17da2d67-85ad-4170-bd4e-1b9ca4565950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216800
Marketing category
ANDA
Marketing start
2024-11-19
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
Rxcui993518

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
68788-8769-1Bupropion hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
68788-8769-2Bupropion hydrochloride20 in 1 BOTTLETABLET, EXTENDED RELEASE202
68788-8769-3Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
68788-8769-6Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
68788-8769-8Bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1202
68788-8769-9Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8769-1EA - Each68788-876977053746-ef3a-4890-9997-0fdd5b4d6b5d12025-02-10
68788-8769-2EA - Each68788-8769bc1cf39f-bcad-416d-8984-b814b33b38d512025-02-10
68788-8769-3EA - Each68788-8769a0c8606c-1020-48b6-9cd5-181de99c81dd12025-02-10
68788-8769-6EA - Each68788-8769c62d51d9-2907-482e-b9e0-f9a2c0685e0812025-02-10
68788-8769-8EA - Each68788-8769a8c5c323-467f-47bf-9c25-a28c448e1cbf12025-02-10
68788-8769-9EA - Each68788-8769f0fe802d-7f66-4fd0-bcbb-6e65303cf03c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8769BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20241122_093c4a61-02d9-4b55-b612-569aa25d3f2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN093c4a61-02d9-4b55-b612-569aa25d3f2a2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD093c4a61-02d9-4b55-b612-569aa25d3f2a2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY093c4a61-02d9-4b55-b612-569aa25d3f2a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8769-168788876901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-1) 2024-11-19NoNoHistorical
68788-8769-26878887690220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-2) 2024-11-19NoNoHistorical
68788-8769-36878887690330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-3) 2024-11-19NoNoHistorical
68788-8769-66878887690660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-6) 2024-11-19NoNoHistorical
68788-8769-868788876908120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-8) 2024-11-19NoNoHistorical
68788-8769-96878887690990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8769-9) 2024-11-19NoNoHistorical