Bupropion Hydrochloride

Product NDC
51655-115
11-digit product format
516550115
Labeler code
51655
Product ID
51655-115_48c3c65d-777b-3c63-e063-6394a90a1176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA211347
Marketing category
ANDA
Marketing start
2022-10-05
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
Rxcui993518

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
51655-115-25Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE603
51655-115-26Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
51655-115-52Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303
51655-115-83Bupropion HydrochlorideSR180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-115BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20240709_f2b3939b-a410-6354-e053-2995a90ababb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf2b3939b-a410-6354-e053-2995a90ababb3
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf2b3939b-a410-6354-e053-2995a90ababb3
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf2b3939b-a410-6354-e053-2995a90ababb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-115-255165501152560 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-115-25) 2022-10-05NoNoHistorical
51655-115-265165501152690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-115-26) 2022-11-15NoNoHistorical
51655-115-525165501155230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-115-52) 2022-11-30NoNoHistorical
51655-115-8351655011583180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-115-83) 2023-01-05NoNoHistorical