FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
42806-416
11-digit product format
428060416
Labeler code
42806
Product ID
42806-416_4bde5d2f-85ee-95da-e063-6394a90aab81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA210015
Marketing category
ANDA
Marketing start
2023-04-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
XL
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-416-05Bupropion HydrochlorideXL500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE5007
42806-416-09Bupropion HydrochlorideXL90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE907
42806-416-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-416-05EA - Each42806-41643594b8f-f75e-4fdf-b51b-ada27aa8317212023-05-05
42806-416-09EA - Each42806-4165a8d5de3-066a-47db-9e17-3cdccfcb5d4412023-05-05
42806-416-30EA - Each42806-4160a876d4d-ca7a-4852-9ed3-e8e60d95582d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-416BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC]6Current NDC, 3 package rows20241222_f79d1422-a9b6-41c2-a46d-22886605f94d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNf79d1422-a9b6-41c2-a46d-22886605f94d7
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNf79d1422-a9b6-41c2-a46d-22886605f94d7
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf79d1422-a9b6-41c2-a46d-22886605f94d7
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDf79d1422-a9b6-41c2-a46d-22886605f94d7
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYf79d1422-a9b6-41c2-a46d-22886605f94d7
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYf79d1422-a9b6-41c2-a46d-22886605f94d7
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN02275c51-6b3e-434a-bdb5-99135e73f1a45
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN9aa3753f-1a0e-4faa-995f-67e29b3207375
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD9aa3753f-1a0e-4faa-995f-67e29b3207375
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD02275c51-6b3e-434a-bdb5-99135e73f1a45
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY9aa3753f-1a0e-4faa-995f-67e29b3207375
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY02275c51-6b3e-434a-bdb5-99135e73f1a45
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNb2e6c30f-a33c-4854-ab19-bc9f658803743
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDb2e6c30f-a33c-4854-ab19-bc9f658803743
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYb2e6c30f-a33c-4854-ab19-bc9f658803743
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN129ce80c-0333-873e-e063-6394a90a33e02
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD129ce80c-0333-873e-e063-6394a90a33e02
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY129ce80c-0333-873e-e063-6394a90a33e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-416-0542806041605500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-416-05) 2023-04-30NoNoCurrent
42806-416-094280604160990 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-416-09) 2023-04-30NoNoCurrent
42806-416-304280604163030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-416-30) 2023-04-30NoNoCurrent