FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
76420-923
11-digit product format
764200923
Labeler code
76420
Product ID
76420-923_4cfac314-25b0-c9c4-e063-6394a90a85e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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 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
76420-923-01Bupropion HydrochlorideXL100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1002
76420-923-05Bupropion HydrochlorideXL500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5002
76420-923-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
76420-923-60Bupropion HydrochlorideXL60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
76420-923-90Bupropion HydrochlorideXL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-923BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASCLEMED USA, INC.]1Current NDC, 5 package rows20250228_d1d0872c-5b11-4e13-a401-b122348e0fa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd1d0872c-5b11-4e13-a401-b122348e0fa72
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd1d0872c-5b11-4e13-a401-b122348e0fa72
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd1d0872c-5b11-4e13-a401-b122348e0fa72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-923-0176420092301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-01) 2025-02-25NoNoHistorical
76420-923-0576420092305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-05) 2025-02-25NoNoHistorical
76420-923-307642009233030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-30) 2025-02-25NoNoHistorical
76420-923-607642009236060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-60) 2025-02-25NoNoHistorical
76420-923-907642009239090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-90) 2025-02-25NoNoHistorical