Bupropion Hydrochloride

Product NDC
63187-766
11-digit product format
631870766
Labeler code
63187
Product ID
63187-766_42428c55-bb9b-44be-a82f-478f6d22500d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
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 Hydrochloride
Brand name suffix
XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541

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
63187-766-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE305
63187-766-60Bupropion HydrochlorideXL60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE605
63187-766-90Bupropion HydrochlorideXL90 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
63187-766-30EA - Each63187-766512b0ab5-f755-4177-95f1-00017673c0d612023-08-08
63187-766-90EA - Each63187-766917dad26-c9fe-441c-9e83-4d139d237d0c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-766BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230825_ec9cbb38-1582-492f-a526-4b3675c55b14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNec9cbb38-1582-492f-a526-4b3675c55b145
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDec9cbb38-1582-492f-a526-4b3675c55b145
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYec9cbb38-1582-492f-a526-4b3675c55b145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-766-306318707663030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-766-30) 2016-11-010000-00-00NoNoCurrent
63187-766-606318707666060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-766-60) 2016-11-010000-00-00NoNoCurrent
63187-766-906318707669090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63187-766-90) 2016-11-010000-00-00NoNoCurrent