FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
68788-7992
11-digit product format
687887992
Labeler code
68788
Product ID
68788-7992_335318d4-0d96-42e7-a3be-a11702751b4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210497
Marketing category
ANDA
Marketing start
2021-08-06
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
68788-7992-1BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
68788-7992-3BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE305
68788-7992-6BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE605
68788-7992-8BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
68788-7992-9BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7992-1EA - Each68788-7992fc4c81a3-eb65-4276-b439-296f611f78e712021-09-07
68788-7992-3EA - Each68788-799208cae977-58a1-4458-bbef-bba6d860ec9012021-09-07
68788-7992-6EA - Each68788-799285aaba95-64b1-4624-a62f-c754d3f9924712021-09-07
68788-7992-8EA - Each68788-7992fbca4807-d647-49a3-9f61-0ff7be5f05b012021-09-07
68788-7992-9EA - Each68788-7992f9b2b2bb-3c85-456c-9453-4cf08d3f56ac12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7992BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 5 package rows20250213_5dec4414-5595-46c9-ada9-3fbe98152040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN5dec4414-5595-46c9-ada9-3fbe981520405
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD5dec4414-5595-46c9-ada9-3fbe981520405
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY5dec4414-5595-46c9-ada9-3fbe981520405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7992-168788799201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7992-1) 2021-08-060000-00-00NoNoCurrent
68788-7992-36878879920330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7992-3) 2021-08-060000-00-00NoNoCurrent
68788-7992-66878879920660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7992-6) 2021-08-060000-00-00NoNoCurrent
68788-7992-868788799208120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7992-8) 2021-08-060000-00-00NoNoCurrent
68788-7992-96878879920990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7992-9) 2021-08-060000-00-00NoNoCurrent