Bupropion Hydrochloride

Product NDC
0904-7530
11-digit product format
009047530
Labeler code
0904
Product ID
0904-7530_b7ffab2d-0ec5-4669-8f6a-d40cf1add983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
ANDA206975
Marketing category
ANDA
Marketing start
2025-01-30
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
Rxcui993687, 993691

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7530-60Bupropion Hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7530-60EA - Each0904-7530712ec542-f412-4f28-95c7-a67731467b2f12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7530BUPROPION HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]1Current NDC, 1 package rows20250201_3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c93
993691buPROPion HCl 75 MG Oral TabletPSN3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c93
993687bupropion hydrochloride 100 MG Oral TabletSCD3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c93
993691bupropion hydrochloride 75 MG Oral TabletSCD3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c93
993691bupropion HCl 75 MG Oral TabletSY3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c93
993687buPROPion HCl 100 MG Oral TabletPSN35a873c5-4aa8-b3c7-e063-6394a90a35ec1
993687bupropion hydrochloride 100 MG Oral TabletSCD35a873c5-4aa8-b3c7-e063-6394a90a35ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7530-6000904753060100 TABLET in 1 BOTTLE (0904-7530-60) 100 tablet2025-01-30NoNoHistorical