FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
71205-504
11-digit product format
712050504
Labeler code
71205
Product ID
71205-504_8ab86beb-3616-414c-92bf-25273a853a9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210497
Marketing category
ANDA
Marketing start
2018-11-08
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
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 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
71205-504-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-504-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-504-90BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-504-30EA - Each71205-50431b0bbae-a387-4cc4-b3c8-c7d186d0175a12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-504BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220702_42201f4a-8856-4499-8bc3-d18612b1ec34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN42201f4a-8856-4499-8bc3-d18612b1ec342
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD42201f4a-8856-4499-8bc3-d18612b1ec342
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY42201f4a-8856-4499-8bc3-d18612b1ec342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-504-307120505043030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-504-30) 2020-11-130000-00-00NoNoCurrent
71205-504-607120505046060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-504-60) 2020-11-130000-00-00NoNoCurrent
71205-504-907120505049090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-504-90) 2020-11-130000-00-00NoNoCurrent