FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
71335-2469
11-digit product format
713352469
Labeler code
71335
Product ID
71335-2469_0c3952f8-d149-4812-bec9-ecf841fe1950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215568
Marketing category
ANDA
Marketing start
2022-12-15
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
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
71335-2469-1Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE30100
71335-2469-2Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE60100
71335-2469-3Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE90100
71335-2469-4Bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE120100
71335-2469-5Bupropion hydrochloride14 in 1 BOTTLETABLET, EXTENDED RELEASE14100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2469-1EA - Each71335-24694803e0f3-0273-4336-abbf-47c27915d1e612025-05-14
71335-2469-3EA - Each71335-2469486de729-f2e8-4ee0-ace5-5314b587f95a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2469BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20241114_af5b1cc8-f078-4a7b-b64a-4cb2de1e5721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2469-17133524690130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2469-1) 2024-11-12NoNoHistorical
71335-2469-27133524690260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2469-2) 2024-11-12NoNoHistorical
71335-2469-37133524690390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2469-3) 2024-11-12NoNoHistorical
71335-2469-471335246904120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2469-4) 2024-11-12NoNoHistorical
71335-2469-57133524690514 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2469-5) 2024-11-12NoNoHistorical