FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
71335-2457
11-digit product format
713352457
Labeler code
71335
Product ID
71335-2457_8f9001c7-e11f-452a-8bbf-4515d87ec8ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216800
Marketing category
ANDA
Marketing start
2023-05-31
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
Rxcui993518

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
71335-2457-1Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
71335-2457-2Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901
71335-2457-3Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
71335-2457-4Bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1201
71335-2457-5Bupropion hydrochloride45 in 1 BOTTLETABLET, EXTENDED RELEASE451
71335-2457-6Bupropion hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1801
71335-2457-7Bupropion hydrochloride28 in 1 BOTTLETABLET, EXTENDED RELEASE281
71335-2457-8Bupropion hydrochloride56 in 1 BOTTLETABLET, EXTENDED RELEASE561
71335-2457-9Bupropion hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2457-1EA - Each71335-24576d08b5dd-c447-4089-9b88-3eb52d62cd2f12026-01-08
71335-2457-3EA - Each71335-2457008d4543-8afc-40d5-8f8e-7f768a2d8a7312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2457BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 9 package rows20240822_4c9a5dc3-bebe-431a-b550-ce46c6c6b01e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN4c9a5dc3-bebe-431a-b550-ce46c6c6b01e1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD4c9a5dc3-bebe-431a-b550-ce46c6c6b01e1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY4c9a5dc3-bebe-431a-b550-ce46c6c6b01e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2457-17133524570160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-1) 2024-08-20NoNoHistorical
71335-2457-27133524570290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-2) 2024-08-20NoNoHistorical
71335-2457-37133524570330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-3) 2024-08-20NoNoHistorical
71335-2457-471335245704120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-4) 2024-08-20NoNoHistorical
71335-2457-57133524570545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-5) 2024-08-20NoNoHistorical
71335-2457-671335245706180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-6) 2024-08-20NoNoHistorical
71335-2457-77133524570728 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-7) 2024-08-20NoNoHistorical
71335-2457-87133524570856 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-8) 2024-08-20NoNoHistorical
71335-2457-971335245709100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2457-9) 2024-08-20NoNoHistorical