FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71610-582
11-digit product format
716100582
Labeler code
71610
Product ID
71610-582_a21c94b7-5512-4999-bb4b-308c6008569c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205794
Marketing category
ANDA
Marketing start
2021-04-15
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993518, 993536

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
71610-582-83Bupropion HydrochlorideSR3600 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE36002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-582-83EA - Each71610-582f6abd746-e4be-4cfc-ab48-7fbeddda508812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-582BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 1 package rows20210822_5f8b3313-0286-499f-9235-02cdc0eb063b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN5f8b3313-0286-499f-9235-02cdc0eb063b2
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN5f8b3313-0286-499f-9235-02cdc0eb063b2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5f8b3313-0286-499f-9235-02cdc0eb063b2
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD5f8b3313-0286-499f-9235-02cdc0eb063b2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY5f8b3313-0286-499f-9235-02cdc0eb063b2
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY5f8b3313-0286-499f-9235-02cdc0eb063b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-582-83716100582833600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-83) 2021-07-150000-00-00NoNoCurrent