FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
42806-413
11-digit product format
428060413
Labeler code
42806
Product ID
42806-413_4bde68a6-0945-b21f-e063-6394a90a3bc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA216766
Marketing category
ANDA
Marketing start
2023-02-28
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
SR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui1801289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-413-60Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-413-60EA - Each42806-41314b189a7-e6de-45ad-931b-26b2fd822ba012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-413BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [EPIC PHARMA, LLC]4Current NDC, 1 package rows20240620_f56ccdb1-f9d9-3e5f-e053-2995a90a8f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSNf56ccdb1-f9d9-3e5f-e053-2995a90a8f165
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf56ccdb1-f9d9-3e5f-e053-2995a90a8f165
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSYf56ccdb1-f9d9-3e5f-e053-2995a90a8f165
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSN383728f0-dc78-49b2-86f8-4942ba7955882
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD383728f0-dc78-49b2-86f8-4942ba7955882
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSY383728f0-dc78-49b2-86f8-4942ba7955882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-413-604280604136060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-413-60) 2023-02-28NoNoCurrent