FDA.reportPublic FDA data

bupropion Hydrochloride

Product NDC
23155-192
11-digit product format
231550192
Labeler code
23155
Product ID
23155-192_b72f6124-e8e4-42b7-8095-771ff429e936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA206975
Marketing category
ANDA
Marketing start
2016-08-19
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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-192-012020-02-18C16284748780-19d75b9d0-ab9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
23155-192-102020-02-18C16284748780-19d75b9d0-ab9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
23155-192-012020-01-31C16284748780-19d75b9d0-ab9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
23155-192-102020-01-31C16284748780-19d75b9d0-ab9d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-192-01bupropion Hydrochloride100 in 1 BOTTLETABLET10017
23155-192-10bupropion Hydrochloride1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-192-01EA - Each23155-192299db334-3198-4d2c-8d9d-553125b78fef12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-192BUPROPION HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 2 package rows20240312_9196568e-aec8-4d56-993e-4cbb78d4a3a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN4971c3cb-07c4-4c65-a16a-f1700e523147101
993687bupropion hydrochloride 100 MG Oral TabletSCD4971c3cb-07c4-4c65-a16a-f1700e523147101
993687buPROPion HCl 100 MG Oral TabletPSNe2a988f2-f8d3-4de0-b9f1-49d8c2e4180f100
993687buPROPion HCl 100 MG Oral TabletPSN744f7394-aac9-4864-9436-e5b0b35a6148100
993687bupropion hydrochloride 100 MG Oral TabletSCDe2a988f2-f8d3-4de0-b9f1-49d8c2e4180f100
993687bupropion hydrochloride 100 MG Oral TabletSCD744f7394-aac9-4864-9436-e5b0b35a6148100
993687buPROPion HCl 100 MG Oral TabletPSN434aacf8-87f1-44fc-a66b-92ae0022de0e18
993687bupropion hydrochloride 100 MG Oral TabletSCD434aacf8-87f1-44fc-a66b-92ae0022de0e18
993687buPROPion HCl 100 MG Oral TabletPSN9196568e-aec8-4d56-993e-4cbb78d4a3a617
993691buPROPion HCl 75 MG Oral TabletPSN9196568e-aec8-4d56-993e-4cbb78d4a3a617
993687bupropion hydrochloride 100 MG Oral TabletSCD9196568e-aec8-4d56-993e-4cbb78d4a3a617
993691bupropion hydrochloride 75 MG Oral TabletSCD9196568e-aec8-4d56-993e-4cbb78d4a3a617
993691bupropion HCl 75 MG Oral TabletSY9196568e-aec8-4d56-993e-4cbb78d4a3a617
993687buPROPion HCl 100 MG Oral TabletPSNd9bbacb3-63b4-2922-e053-2a95a90a60854
993687bupropion hydrochloride 100 MG Oral TabletSCDd9bbacb3-63b4-2922-e053-2a95a90a60854
993687buPROPion HCl 100 MG Oral TabletPSN90cc4f07-e0a3-4d50-a10a-8f6a7f9c51402
993687bupropion hydrochloride 100 MG Oral TabletSCD90cc4f07-e0a3-4d50-a10a-8f6a7f9c51402
993687buPROPion HCl 100 MG Oral TabletPSN507112bd-a082-e85a-e063-6294a90ab2ac1
993687buPROPion HCl 100 MG Oral TabletPSNaa5426ec-74f3-5a86-e053-2995a90ae4bd1
993687bupropion hydrochloride 100 MG Oral TabletSCDaa5426ec-74f3-5a86-e053-2995a90ae4bd1
993687bupropion hydrochloride 100 MG Oral TabletSCD507112bd-a082-e85a-e063-6294a90ab2ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-192-0123155019201100 TABLET in 1 BOTTLE (23155-192-01) 100 tablet2016-08-190000-00-00NoNoCurrent
23155-192-10231550192101000 TABLET in 1 BOTTLE (23155-192-10) 1000 tablet2016-08-190000-00-00NoNoCurrent