FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0615-8505
11-digit product format
006158505
Labeler code
0615
Product ID
0615-8505_31890576-e68d-4449-b0dd-205175720f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA211020
Marketing category
ANDA
Marketing start
2022-08-01
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
0615-8505-05Bupropion Hydrochloride15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE152
0615-8505-39Bupropion Hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8505BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 2 package rows20240814_aeb506f8-97c2-409a-aac9-5a73c840e8f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8505-050061585050515 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8505-05) 2024-07-12NoNoCurrent
0615-8505-390061585053930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8505-39) 2024-03-15NoNoCurrent