FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
43353-767
11-digit product format
433530767
Labeler code
43353
Product ID
43353-767_935e87ee-39e2-46b7-94c1-9d3b88057ff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075584
Marketing category
ANDA
Marketing start
2000-02-07
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
43353-767-532020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP
43353-767-602020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP
43353-767-702020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP
43353-767-802020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP
43353-767-832020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP
43353-767-922020-01-31C16284748780-19d75b9d1-2b1d-f424-e053-dadaa90a57ceBuPROPion Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-767-53Bupropion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
43353-767-60Bupropion Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
43353-767-70Bupropion Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1203
43353-767-80Bupropion Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1803
43353-767-83Bupropion Hydrochloride3600 in 1 BOTTLE, PLASTICTABLET, FILM COATED36003
43353-767-92Bupropion Hydrochloride270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-767-53EA - Each43353-767d1465be7-39a7-4b9f-832c-a2dd2d8d60d412012-07-24
43353-767-60EA - Each43353-7673c8c4998-d266-4a7a-af92-f21c9be68e5912012-07-24
43353-767-70EA - Each43353-767e62df1ee-c30a-4f39-bb03-53114cbc978512012-07-24
43353-767-80EA - Each43353-7672abd9923-4842-4965-9d81-8581e34423c312012-07-24
43353-767-83EA - Each43353-76786855cdc-3ea4-4f42-8448-5722d605ba4d12015-01-05
43353-767-92EA - Each43353-767a10960c3-5492-43d2-86c8-6d5e99ddcdec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-767BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 6 package rows20140521_6e636f4a-e649-426d-ae34-e599e3f9c926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN6e636f4a-e649-426d-ae34-e599e3f9c9263
993687bupropion hydrochloride 100 MG Oral TabletSCD6e636f4a-e649-426d-ae34-e599e3f9c9263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-767-534335307675360 in 1 BOTTLE, PLASTICHistorical
43353-767-604335307676090 in 1 BOTTLE, PLASTICHistorical
43353-767-7043353076770120 in 1 BOTTLE, PLASTICHistorical
43353-767-8043353076780180 in 1 BOTTLE, PLASTICHistorical
43353-767-83433530767833600 in 1 BOTTLE, PLASTICHistorical
43353-767-9243353076792270 in 1 BOTTLE, PLASTICHistorical