FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
68788-7786
11-digit product format
687887786
Labeler code
68788
Product ID
68788-7786_7592d5b6-97f7-4c5b-ae4d-684725f1f139
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
2020-10-21
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

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
68788-7786-1BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
68788-7786-3BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE307
68788-7786-6BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE607
68788-7786-8BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1207
68788-7786-9BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7786BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250213_42e228a2-25b3-44a6-8da7-6616ca44ac7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN42e228a2-25b3-44a6-8da7-6616ca44ac7f7
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD42e228a2-25b3-44a6-8da7-6616ca44ac7f7
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY42e228a2-25b3-44a6-8da7-6616ca44ac7f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7786-168788778601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7786-1) 2020-10-210000-00-00NoNoCurrent
68788-7786-36878877860330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7786-3) 2020-10-210000-00-00NoNoCurrent
68788-7786-66878877860660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7786-6) 2020-10-210000-00-00NoNoCurrent
68788-7786-868788778608120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7786-8) 2020-10-210000-00-00NoNoCurrent
68788-7786-96878877860990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7786-9) 2020-10-210000-00-00NoNoCurrent