FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
71335-1044
11-digit product format
713351044
Labeler code
71335
Product ID
71335-1044_7c21c838-0b41-4b45-90a5-db13665c0074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1044-1BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
71335-1044-2BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE6012
71335-1044-3BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE9012
71335-1044-4BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE12012
71335-1044-5BUPROPION HYDROCHLORIDE14 in 1 BOTTLETABLET, EXTENDED RELEASE1412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1044-1EA - Each71335-1044993e88b3-054c-491d-a0d9-cbbdd692c43c12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1044BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 5 package rows20240830_7c46d95a-26f6-4364-8197-9e564e3405f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN7c46d95a-26f6-4364-8197-9e564e3405f212
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7c46d95a-26f6-4364-8197-9e564e3405f212
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY7c46d95a-26f6-4364-8197-9e564e3405f212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1044-17133510440130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1044-1) 2019-01-030000-00-00NoNoCurrent
71335-1044-27133510440260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1044-2) 2020-06-100000-00-00NoNoCurrent
71335-1044-37133510440390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1044-3) 2019-02-280000-00-00NoNoCurrent
71335-1044-471335104404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1044-4) 2021-12-280000-00-00NoNoCurrent
71335-1044-57133510440514 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1044-5) 2021-12-280000-00-00NoNoCurrent