FDA.reportPublic FDA data

bupropion

Product NDC
68382-353
11-digit product format
683820353
Labeler code
68382
Product ID
68382-353_00be046c-e051-4430-a967-3a0d4611da22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-353-05bupropion500 in 1 BOTTLETABLET, EXTENDED RELEASE50020
68382-353-06bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE3020
68382-353-10bupropion1000 in 1 BOTTLETABLET, EXTENDED RELEASE100020
68382-353-16bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-353-05EA - Each68382-35332778398-a905-4dd1-91ac-f0060f49712712019-01-24
68382-353-06EA - Each68382-353e50a50af-f878-4261-9f09-77a376d8db9c12019-01-24
68382-353-16EA - Each68382-353ba846cad-72d6-4d2e-b9e8-00560e28511912019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-353BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 4 package rows20240525_8d937ca3-3351-40f1-8192-348ba0c68162.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN8d937ca3-3351-40f1-8192-348ba0c6816220
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8d937ca3-3351-40f1-8192-348ba0c6816220
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8d937ca3-3351-40f1-8192-348ba0c6816220
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8d937ca3-3351-40f1-8192-348ba0c6816220
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY8d937ca3-3351-40f1-8192-348ba0c6816220
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8d937ca3-3351-40f1-8192-348ba0c6816220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-353-0568382035305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-05) 2018-08-020000-00-00NoNoCurrent
68382-353-066838203530630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-06) 2018-08-020000-00-00NoNoCurrent
68382-353-10683820353101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-10) 2018-08-020000-00-00NoNoCurrent
68382-353-166838203531690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-16) 2018-08-020000-00-00NoNoCurrent