FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
68001-520
11-digit product format
680010520
Labeler code
68001
Product ID
68001-520_2a90f7e8-2e30-7358-e063-6394a90a71a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA210497
Marketing category
ANDA
Marketing start
2021-12-13
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
68001-520-03BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
68001-520-04BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE304
68001-520-05BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-520-03EA - Each68001-520c475d908-6fa9-4168-8799-967890810ad112022-03-09
68001-520-04EA - Each68001-520243c7cd7-30e4-4601-adfd-3d92beebf7e212022-03-09
68001-520-05EA - Each68001-520691fb2d3-37de-4d38-af9a-55311afb56a512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-520BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]4Current NDC, Legacy NDC, 3 package rows20250101_5ccec958-998d-43a1-86fb-eb2b5e697b77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN5ccec958-998d-43a1-86fb-eb2b5e697b774
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN5ccec958-998d-43a1-86fb-eb2b5e697b774
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5ccec958-998d-43a1-86fb-eb2b5e697b774
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD5ccec958-998d-43a1-86fb-eb2b5e697b774
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY5ccec958-998d-43a1-86fb-eb2b5e697b774
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY5ccec958-998d-43a1-86fb-eb2b5e697b774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-520-0368001052003500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-520-03) 2021-12-130000-00-00NoNoCurrent
68001-520-046800105200430 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-520-04) 2021-12-130000-00-00NoNoCurrent
68001-520-056800105200590 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-520-05) 2021-12-130000-00-00NoNoCurrent