FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
71335-1214
11-digit product format
713351214
Labeler code
71335
Product ID
71335-1214_4e5c9883-8fbd-443f-a356-b0793cd27687
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
2019-03-25
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O

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
71335-1214-1BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
71335-1214-2BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE60103
71335-1214-3BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE90103
71335-1214-4BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE120103
71335-1214-5BUPROPION HYDROCHLORIDE8 in 1 BOTTLETABLET, EXTENDED RELEASE8103
71335-1214-6BUPROPION HYDROCHLORIDE180 in 1 BOTTLETABLET, EXTENDED RELEASE180103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1214-1EA - Each71335-1214f191c7d2-751d-4cfc-88b7-049bb117084112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1214BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240823_82bcdd72-9146-4c8d-a8aa-f92015864605.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN82bcdd72-9146-4c8d-a8aa-f92015864605103
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD82bcdd72-9146-4c8d-a8aa-f92015864605103
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY82bcdd72-9146-4c8d-a8aa-f92015864605103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1214-17133512140130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-1) 2019-05-030000-00-00NoNoCurrent
71335-1214-27133512140260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-2) 2021-04-220000-00-00NoNoCurrent
71335-1214-37133512140390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-3) 2019-06-100000-00-00NoNoCurrent
71335-1214-471335121404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-4) 2019-05-290000-00-00NoNoCurrent
71335-1214-5713351214058 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-5) 2024-08-090000-00-00NoNoCurrent
71335-1214-671335121406180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1214-6) 2024-08-09NoNoCurrent