FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
63187-952
11-digit product format
631870952
Labeler code
63187
Product ID
63187-952_3bfee467-f720-4aa7-aeff-6b07c1618808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-03-24
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503

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
63187-952-14Bupropion HydrochlorideSR14 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE145
63187-952-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE305
63187-952-60Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE605
63187-952-90Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-952-14EA - Each63187-95221073042-58ac-47b3-8b33-5e690dcc5ecc12024-06-10
63187-952-30EA - Each63187-95271dfc3aa-7906-4d54-8c97-05312db11ded12023-04-07
63187-952-60EA - Each63187-952fa7ce361-cff7-4502-b269-8d82cc586a6c12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-952BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20240511_b59d950c-341f-45f1-b5b2-d64ccc799580.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNb59d950c-341f-45f1-b5b2-d64ccc7995805
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDb59d950c-341f-45f1-b5b2-d64ccc7995805
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYb59d950c-341f-45f1-b5b2-d64ccc7995805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-952-146318709521414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-14) 2024-05-07NoNoCurrent
63187-952-306318709523030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-30) 2018-01-010000-00-00NoNoCurrent
63187-952-606318709526060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-60) 2018-01-010000-00-00NoNoCurrent
63187-952-906318709529090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-952-90) 2018-01-010000-00-00NoNoCurrent