FDA.reportPublic FDA data

Forfivo

Product NDC
24979-247
11-digit product format
249790247
Labeler code
24979
Product ID
24979-247_96a5dcb3-5d09-4357-96e3-8005ef094b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA022497
Marketing category
NDA
Marketing start
2023-12-15
Substance
BUPROPION HYDROCHLORIDE
Active strength
450 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
Forfivo
Brand name suffix
XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE450 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui1232585, 1232591

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
24979-247-06Forfivo XL30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-247FORFIVO XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20240514_80b01182-dc94-4990-8ebb-55c306d7e536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232585buPROPion HCl 450 MG 24HR Extended Release Oral TabletPSN80b01182-dc94-4990-8ebb-55c306d7e5368
1232591Forfivo XL 450 MG 24HR Extended Release Oral TabletPSN80b01182-dc94-4990-8ebb-55c306d7e5368
123259124 HR bupropion hydrochloride 450 MG Extended Release Oral Tablet [Forfivo]SBD80b01182-dc94-4990-8ebb-55c306d7e5368
123258524 HR bupropion hydrochloride 450 MG Extended Release Oral TabletSCD80b01182-dc94-4990-8ebb-55c306d7e5368
123259124 HR Forfivo 450 MG Extended Release Oral TabletSY80b01182-dc94-4990-8ebb-55c306d7e5368
1232585bupropion hydrochloride 450 MG 24 HR Extended Release Oral TabletSY80b01182-dc94-4990-8ebb-55c306d7e5368
1232591Forfivo XL 450 MG 24 HR Extended Release Oral TabletSY80b01182-dc94-4990-8ebb-55c306d7e5368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-247-062497902470630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-247-06) 2023-12-15NoNoCurrent