FDA.reportPublic FDA data

buPropion Hydrochloride

Product NDC
72516-036
11-digit product format
725160036
Labeler code
72516
Product ID
72516-036_47afeb95-a677-8969-e063-6294a90a7b2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oryza pharmaceuticals Inc.
Application
ANDA211200
Marketing category
ANDA
Marketing start
2019-09-06
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
buPropion Hydrochloride
Brand name suffix
XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
72516-036-03buPropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE303
72516-036-09buPropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE903
72516-036-50buPropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-036-50EA - Each72516-036279b6a72-92d6-4af9-b230-9c93b8c0185612026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN004d8121-59d4-46c4-acb8-b2dd097bf5563
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN004d8121-59d4-46c4-acb8-b2dd097bf5563
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD004d8121-59d4-46c4-acb8-b2dd097bf5563
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD004d8121-59d4-46c4-acb8-b2dd097bf5563
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY004d8121-59d4-46c4-acb8-b2dd097bf5563
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY004d8121-59d4-46c4-acb8-b2dd097bf5563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72516-036-037251600360330 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-03) 2019-09-06NoNoCurrent
72516-036-097251600360990 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-09) 2019-09-06NoNoCurrent
72516-036-5072516003650500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-036-50) 2019-09-06NoNoCurrent