Bupropion Hydrochloride

Product NDC
71205-291
11-digit product format
712050291
Labeler code
71205
Product ID
71205-291_ee865180-23ee-4b72-a56e-30db9551dddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207224
Marketing category
ANDA
Marketing start
2017-10-01
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
Brand name suffix
XL
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
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
71205-291-30Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE304
71205-291-60Bupropion HydrochlorideXL60 in 1 BOTTLETABLET, EXTENDED RELEASE604
71205-291-90Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-291-30EA - Each71205-29123a02621-7f4a-4db4-b223-6f88c2a5c5cf12019-11-12
71205-291-90EA - Each71205-2915b0e96ea-2c47-4dd3-b97f-62836e1cf9d012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-291BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221110_5e568bb5-542a-4395-a21e-dc64281d694e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN5e568bb5-542a-4395-a21e-dc64281d694e4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5e568bb5-542a-4395-a21e-dc64281d694e4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY5e568bb5-542a-4395-a21e-dc64281d694e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-291-307120502913030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-291-30) 2019-07-010000-00-00NoNoCurrent
71205-291-607120502916060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-291-60) 2019-07-010000-00-00NoNoCurrent
71205-291-907120502919090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-291-90) 2019-07-010000-00-00NoNoCurrent