FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
63304-724
11-digit product format
633040724
Labeler code
63304
Product ID
63304-724_45fe80b5-18e6-7710-e063-6394a90ad334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA203650
Marketing category
ANDA
Marketing start
2021-01-01
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
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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
63304-724-05Bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50013
63304-724-30Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
63304-724-90Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-724-05EA - Each63304-72465bb0161-6393-45b5-8e1a-ba407b5705a512021-02-05
63304-724-30EA - Each63304-7241864f206-2ff1-4082-b4bb-876b3ad3a33512021-02-05
63304-724-90EA - Each63304-724b804bf78-72f2-40ba-9568-6c09ee07f8b712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-724BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 3 package rows20240604_fddb7191-c4f9-4e82-bd7d-259c3767710a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNfddb7191-c4f9-4e82-bd7d-259c3767710a13
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDfddb7191-c4f9-4e82-bd7d-259c3767710a13
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYfddb7191-c4f9-4e82-bd7d-259c3767710a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-724-0563304072405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-05) 2021-01-010000-00-00NoNoCurrent
63304-724-306330407243030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-30) 2021-01-010000-00-00NoNoCurrent
63304-724-906330407249090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-90) 2021-01-010000-00-00NoNoCurrent