FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71205-968
11-digit product format
712050968
Labeler code
71205
Product ID
71205-968_f2be86a1-5401-4b68-a675-95b44c43a5f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
Brand name suffix
(XL)
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
71205-968-30Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
71205-968-55Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE5002
71205-968-90Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-968-30EA - Each71205-9686bc9d293-4642-41d7-8170-016513553b4912021-06-02
71205-968-55EA - Each71205-96831424c2a-1366-448e-897d-d4c44b995ea112021-06-02
71205-968-90EA - Each71205-968011670b1-0613-4e65-b347-62817d00ed9712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-968BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220426_2af578d8-a7f8-4da3-b126-390a0e950fad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN2af578d8-a7f8-4da3-b126-390a0e950fad2
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN2af578d8-a7f8-4da3-b126-390a0e950fad2
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD2af578d8-a7f8-4da3-b126-390a0e950fad2
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD2af578d8-a7f8-4da3-b126-390a0e950fad2
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY2af578d8-a7f8-4da3-b126-390a0e950fad2
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY2af578d8-a7f8-4da3-b126-390a0e950fad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-968-307120509683030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-968-30) 2020-06-090000-00-00NoNoCurrent
71205-968-5571205096855500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-968-55) 2020-06-090000-00-00NoNoCurrent
71205-968-907120509689090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71205-968-90) 2020-06-090000-00-00NoNoCurrent