FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
60505-0158
11-digit product format
605050158
Labeler code
60505
Product ID
60505-0158_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
75 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 HYDROCHLORIDE75 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
60505-0158-1Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10022
60505-0158-3Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
60505-0158-5Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50022
60505-0158-7Bupropion Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100022
60505-0158-9Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0158-1EA - Each60505-0158c53dc1e1-33a2-469d-9acc-938b4a9ec11a12012-07-24
60505-0158-5EA - Each60505-01586c4fc750-14e9-411a-91bc-cded606d076b12012-07-24
60505-0158-9EA - Each60505-0158a041eab0-6dd1-4b99-b207-7f1b977168e612012-07-24

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
60505-0158BUPROPION 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
993691buPROPion HCl 75 MG Oral TabletPSN1d722dc2-7909-454e-b989-095677079044106
993691bupropion hydrochloride 75 MG Oral TabletSCD1d722dc2-7909-454e-b989-095677079044106
993691bupropion HCl 75 MG Oral TabletSY1d722dc2-7909-454e-b989-095677079044106
993691buPROPion HCl 75 MG Oral TabletPSNf566f8b5-b3c1-4234-88bd-59a7b8dc801a104
993691bupropion hydrochloride 75 MG Oral TabletSCDf566f8b5-b3c1-4234-88bd-59a7b8dc801a104
993691bupropion HCl 75 MG Oral TabletSYf566f8b5-b3c1-4234-88bd-59a7b8dc801a104
993691buPROPion HCl 75 MG Oral TabletPSNb5c12c9a-62eb-481a-8099-7ad35242f7bf23
993691bupropion hydrochloride 75 MG Oral TabletSCDb5c12c9a-62eb-481a-8099-7ad35242f7bf23
993691bupropion HCl 75 MG Oral TabletSYb5c12c9a-62eb-481a-8099-7ad35242f7bf23
993687buPROPion HCl 100 MG Oral TabletPSN86530199-999b-9f92-b1bc-b8515ec829f322
993691buPROPion HCl 75 MG Oral TabletPSN86530199-999b-9f92-b1bc-b8515ec829f322
993687bupropion hydrochloride 100 MG Oral TabletSCD86530199-999b-9f92-b1bc-b8515ec829f322
993691bupropion hydrochloride 75 MG Oral TabletSCD86530199-999b-9f92-b1bc-b8515ec829f322
993691bupropion HCl 75 MG Oral TabletSY86530199-999b-9f92-b1bc-b8515ec829f322
993691buPROPion HCl 75 MG Oral TabletPSN3b73d56e-e558-49de-8126-d7ec9b67a08618
993691bupropion hydrochloride 75 MG Oral TabletSCD3b73d56e-e558-49de-8126-d7ec9b67a08618
993691bupropion HCl 75 MG Oral TabletSY3b73d56e-e558-49de-8126-d7ec9b67a08618
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 TabletSCDb127d3fc-be5e-4c12-8026-205766bf8e7f8
993687bupropion hydrochloride 100 MG Oral TabletSCDbcb4ef83-f272-4090-8547-9aaf4ab636678
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 TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691buPROPion HCl 75 MG Oral TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687bupropion hydrochloride 100 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691bupropion hydrochloride 75 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691bupropion HCl 75 MG Oral TabletSY234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691buPROPion HCl 75 MG Oral TabletPSNaef84c3a-68e2-e9d9-e053-2995a90a4ab83
993691bupropion hydrochloride 75 MG Oral TabletSCDaef84c3a-68e2-e9d9-e053-2995a90a4ab83
993691bupropion HCl 75 MG Oral TabletSYaef84c3a-68e2-e9d9-e053-2995a90a4ab83
993687buPROPion HCl 100 MG Oral TabletPSN13560bf8-eb25-44f0-968e-db70d51219af1
993687buPROPion HCl 100 MG Oral TabletPSN59783eee-adc5-3327-e053-2991aa0ab6f51
993691buPROPion HCl 75 MG Oral TabletPSN1391be1b-5e28-1c60-e063-6294a90acf1a1
993691buPROPion HCl 75 MG Oral TabletPSN13560bf8-eb25-44f0-968e-db70d51219af1
993691buPROPion HCl 75 MG Oral TabletPSN4e203e80-fe46-4783-b19c-455e26c32e9d1
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
993691bupropion hydrochloride 75 MG Oral TabletSCD13560bf8-eb25-44f0-968e-db70d51219af1
993691bupropion hydrochloride 75 MG Oral TabletSCD4e203e80-fe46-4783-b19c-455e26c32e9d1
993691bupropion hydrochloride 75 MG Oral TabletSCD1391be1b-5e28-1c60-e063-6294a90acf1a1
993691bupropion hydrochloride 75 MG Oral TabletSCD59783eee-adc5-3327-e053-2991aa0ab6f51
993691bupropion HCl 75 MG Oral TabletSY4e203e80-fe46-4783-b19c-455e26c32e9d1
993691bupropion HCl 75 MG Oral TabletSY13560bf8-eb25-44f0-968e-db70d51219af1
993691bupropion HCl 75 MG Oral TabletSY1391be1b-5e28-1c60-e063-6294a90acf1a1
993691bupropion HCl 75 MG Oral TabletSY59783eee-adc5-3327-e053-2991aa0ab6f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0158-160505015801100 TABLET, FILM COATED in 1 BOTTLE (60505-0158-1) 2006-01-170000-00-00NoNoCurrent
60505-0158-36050501580330 TABLET, FILM COATED in 1 BOTTLE (60505-0158-3) 2006-01-170000-00-00NoNoCurrent
60505-0158-560505015805500 TABLET, FILM COATED in 1 BOTTLE (60505-0158-5) 2006-01-170000-00-00NoNoCurrent
60505-0158-7605050158071000 TABLET, FILM COATED in 1 BOTTLE (60505-0158-7) 2006-01-170000-00-00NoNoCurrent
60505-0158-96050501580990 TABLET, FILM COATED in 1 BOTTLE (60505-0158-9) 2006-01-170000-00-00NoNoCurrent