FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
60505-0157
11-digit product format
605050157
Labeler code
60505
Product ID
60505-0157_cf3f7cdc-3541-a71a-08c5-a74345180a3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp
Application
ANDA076143
Marketing category
ANDA
Marketing start
2006-01-17
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
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
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
60505-0157-1Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10022
60505-0157-3Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
60505-0157-5Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50022
60505-0157-7Bupropion Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100022
60505-0157-9Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0157-1EA - Each60505-0157be56917c-634b-4a7b-af82-10e3d890a74712012-07-24
60505-0157-5EA - Each60505-01570b58272b-69c3-41c6-8a88-8dd778c52e1212012-07-24
60505-0157-9EA - Each60505-0157461c95c8-bb77-4675-800c-46a13d5c4fa012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0157BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP]18Current NDC, Legacy NDC, 5 package rows20240523_86530199-999b-9f92-b1bc-b8515ec829f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNfa5fa0d8-d27f-44e1-8868-dfa7206524e2104
993687bupropion hydrochloride 100 MG Oral TabletSCDfa5fa0d8-d27f-44e1-8868-dfa7206524e2104
993687buPROPion HCl 100 MG Oral TabletPSN86530199-999b-9f92-b1bc-b8515ec829f322
993687buPROPion HCl 100 MG Oral TabletPSN2a13267f-c47f-4791-a8f9-4bbb5c80402722
993691buPROPion HCl 75 MG Oral TabletPSN86530199-999b-9f92-b1bc-b8515ec829f322
993687bupropion hydrochloride 100 MG Oral TabletSCD86530199-999b-9f92-b1bc-b8515ec829f322
993687bupropion hydrochloride 100 MG Oral TabletSCD2a13267f-c47f-4791-a8f9-4bbb5c80402722
993691bupropion hydrochloride 75 MG Oral TabletSCD86530199-999b-9f92-b1bc-b8515ec829f322
993691bupropion HCl 75 MG Oral TabletSY86530199-999b-9f92-b1bc-b8515ec829f322
993687buPROPion HCl 100 MG Oral TabletPSN867d3876-6974-4e89-bc45-9e60e84b401c17
993687bupropion hydrochloride 100 MG Oral TabletSCD867d3876-6974-4e89-bc45-9e60e84b401c17
993687buPROPion HCl 100 MG Oral TabletPSN78ef709a-f835-4b03-92dd-16a4c82af0c116
993687bupropion hydrochloride 100 MG Oral TabletSCD78ef709a-f835-4b03-92dd-16a4c82af0c116
993687buPROPion HCl 100 MG Oral TabletPSN9490d611-b679-45c7-e053-2a95a90afb879
993691buPROPion HCl 75 MG Oral TabletPSN9490d611-b679-45c7-e053-2a95a90afb879
993687bupropion hydrochloride 100 MG Oral TabletSCD9490d611-b679-45c7-e053-2a95a90afb879
993691bupropion hydrochloride 75 MG Oral TabletSCD9490d611-b679-45c7-e053-2a95a90afb879
993691bupropion HCl 75 MG Oral TabletSY9490d611-b679-45c7-e053-2a95a90afb879
993687buPROPion HCl 100 MG Oral TabletPSNb127d3fc-be5e-4c12-8026-205766bf8e7f8
993687buPROPion HCl 100 MG Oral TabletPSNbcb4ef83-f272-4090-8547-9aaf4ab636678
993691buPROPion HCl 75 MG Oral TabletPSNbcb4ef83-f272-4090-8547-9aaf4ab636678
993691buPROPion HCl 75 MG Oral TabletPSNb127d3fc-be5e-4c12-8026-205766bf8e7f8
993687bupropion hydrochloride 100 MG Oral TabletSCDbcb4ef83-f272-4090-8547-9aaf4ab636678
993687bupropion hydrochloride 100 MG Oral TabletSCDb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691bupropion hydrochloride 75 MG Oral TabletSCDbcb4ef83-f272-4090-8547-9aaf4ab636678
993691bupropion hydrochloride 75 MG Oral TabletSCDb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691bupropion HCl 75 MG Oral TabletSYb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691bupropion HCl 75 MG Oral TabletSYbcb4ef83-f272-4090-8547-9aaf4ab636678
993687buPROPion HCl 100 MG Oral TabletPSNeabb54b7-164c-4de8-b91a-f2e65637b5fc7
993687bupropion hydrochloride 100 MG Oral TabletSCDeabb54b7-164c-4de8-b91a-f2e65637b5fc7
993687buPROPion HCl 100 MG Oral TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687buPROPion HCl 100 MG Oral TabletPSNd1043c87-0abe-ee8e-e053-2a95a90a419a4
993691buPROPion HCl 75 MG Oral TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687bupropion hydrochloride 100 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687bupropion hydrochloride 100 MG Oral TabletSCDd1043c87-0abe-ee8e-e053-2a95a90a419a4
993691bupropion hydrochloride 75 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691bupropion HCl 75 MG Oral TabletSY234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687buPROPion HCl 100 MG Oral TabletPSNf820ad7d-3c88-4a4f-e053-6294a90aef7b2
993687bupropion hydrochloride 100 MG Oral TabletSCDf820ad7d-3c88-4a4f-e053-6294a90aef7b2
993687buPROPion HCl 100 MG Oral TabletPSN13560bf8-eb25-44f0-968e-db70d51219af1
993687buPROPion HCl 100 MG Oral TabletPSN7d81ed30-ddf7-431a-84f8-6c630cf2b9771
993687buPROPion HCl 100 MG Oral TabletPSN5e85b398-206e-44fd-a64e-852b2e0f89851
993687buPROPion HCl 100 MG Oral TabletPSN362504fd-2f0a-c097-e063-6394a90ac0fc1
993687buPROPion HCl 100 MG Oral TabletPSN59783eee-adc5-3327-e053-2991aa0ab6f51
993691buPROPion HCl 75 MG Oral TabletPSN13560bf8-eb25-44f0-968e-db70d51219af1
993691buPROPion HCl 75 MG Oral TabletPSN59783eee-adc5-3327-e053-2991aa0ab6f51
993687bupropion hydrochloride 100 MG Oral TabletSCD59783eee-adc5-3327-e053-2991aa0ab6f51
993687bupropion hydrochloride 100 MG Oral TabletSCD13560bf8-eb25-44f0-968e-db70d51219af1
993687bupropion hydrochloride 100 MG Oral TabletSCD362504fd-2f0a-c097-e063-6394a90ac0fc1
993687bupropion hydrochloride 100 MG Oral TabletSCD5e85b398-206e-44fd-a64e-852b2e0f89851
993687bupropion hydrochloride 100 MG Oral TabletSCD7d81ed30-ddf7-431a-84f8-6c630cf2b9771
993691bupropion hydrochloride 75 MG Oral TabletSCD13560bf8-eb25-44f0-968e-db70d51219af1
993691bupropion hydrochloride 75 MG Oral TabletSCD59783eee-adc5-3327-e053-2991aa0ab6f51
993691bupropion HCl 75 MG Oral TabletSY59783eee-adc5-3327-e053-2991aa0ab6f51
993691bupropion HCl 75 MG Oral TabletSY13560bf8-eb25-44f0-968e-db70d51219af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0157-160505015701100 TABLET, FILM COATED in 1 BOTTLE (60505-0157-1) 2006-01-170000-00-00NoNoCurrent
60505-0157-36050501570330 TABLET, FILM COATED in 1 BOTTLE (60505-0157-3) 2006-01-170000-00-00NoNoCurrent
60505-0157-560505015705500 TABLET, FILM COATED in 1 BOTTLE (60505-0157-5) 2006-01-170000-00-00NoNoCurrent
60505-0157-7605050157071000 TABLET, FILM COATED in 1 BOTTLE (60505-0157-7) 2006-01-170000-00-00NoNoCurrent
60505-0157-96050501570990 TABLET, FILM COATED in 1 BOTTLE (60505-0157-9) 2006-01-170000-00-00NoNoCurrent