FDA.reportPublic FDA data

bupropion

Product NDC
65841-836
11-digit product format
658410836
Labeler code
65841
Product ID
65841-836_6c831525-a7c2-4ef1-b1b9-c7e8cb807ded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA201567
Marketing category
ANDA
Marketing start
2018-08-02
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
65841-836-05bupropion500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
65841-836-06bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
65841-836-10bupropion1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011
65841-836-16bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SHELLACINACTIVE INGREDIENT46N107B71OBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RBUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-836BUPROPION TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 4 package rows20241128_78d34aad-9d4f-48c4-91eb-536e31c6b6c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN78d34aad-9d4f-48c4-91eb-536e31c6b6c911
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD78d34aad-9d4f-48c4-91eb-536e31c6b6c911
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY78d34aad-9d4f-48c4-91eb-536e31c6b6c911
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY78d34aad-9d4f-48c4-91eb-536e31c6b6c911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-836-0565841083605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-05) 2018-08-020000-00-00NoNoCurrent
65841-836-066584108360630 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-06) 2018-08-020000-00-00NoNoCurrent
65841-836-10658410836101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-10) 2018-08-020000-00-00NoNoCurrent
65841-836-166584108361690 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-836-16) 2018-08-020000-00-00NoNoCurrent