FDA.reportPublic FDA data

Bupropion HCL ER (XL)

Product NDC
61919-558
11-digit product format
619190558
Labeler code
61919
Product ID
61919-558_4c4a1599-23d9-4beb-e063-6294a90a2c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion HCL ER (XL)
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090693
Marketing category
ANDA
Marketing start
2024-02-15
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 HCL ER (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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
61919-558-60Bupropion HCL ER (XL)60 in 1 BOTTLETABLET, EXTENDED RELEASE603
61919-558-72Bupropion HCL ER (XL)120 in 1 BOTTLETABLET, EXTENDED RELEASE1203
61919-558-90Bupropion HCL ER (XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-558BUPROPION HCL ER (XL) TABLET, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 3 package rows20250227_116cc898-66d6-e3a9-e063-6294a90a67fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN116cc898-66d6-e3a9-e063-6294a90a67fb3
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD116cc898-66d6-e3a9-e063-6294a90a67fb3
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY116cc898-66d6-e3a9-e063-6294a90a67fb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61919-558-606191905586060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-60) 2024-02-15NoNoCurrent
61919-558-7261919055872120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-72) 2024-02-15NoNoCurrent
61919-558-906191905589090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-558-90) 2024-02-15NoNoCurrent