FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
42806-349
11-digit product format
428060349
Labeler code
42806
Product ID
42806-349_b271a757-875d-4349-8c40-a047c10cbd1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA207224
Marketing category
ANDA
Marketing start
2017-10-01
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
Brand name suffix
XL
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
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42806-349-052021-02-03C16284748780-1ba0f9c33-2a0d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE Extended-Release tablets (XL), for oral use Initial U.S. Approval: 1985
42806-349-092021-02-03C16284748780-1ba0f9c33-2a0d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE Extended-Release tablets (XL), for oral use Initial U.S. Approval: 1985
42806-349-052021-01-29C16284748780-1ba0f9c33-2a0d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE Extended-Release tablets (XL), for oral use Initial U.S. Approval: 1985
42806-349-092021-01-29C16284748780-1ba0f9c33-2a0d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE Extended-Release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-349-05Bupropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
42806-349-09Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-349-05EA - Each42806-34996f0ba2b-aa9a-416b-800d-2563fe2ef2ce12017-11-06
42806-349-09EA - Each42806-349520cc9d9-7764-405f-bcfc-120829d9eb8912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-349BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC]5Current NDC, Legacy NDC, 2 package rows20210204_178c7129-a752-4ad9-ac82-4473e23bbacc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN178c7129-a752-4ad9-ac82-4473e23bbacc5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN178c7129-a752-4ad9-ac82-4473e23bbacc5
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD178c7129-a752-4ad9-ac82-4473e23bbacc5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD178c7129-a752-4ad9-ac82-4473e23bbacc5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY178c7129-a752-4ad9-ac82-4473e23bbacc5
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY178c7129-a752-4ad9-ac82-4473e23bbacc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-349-0542806034905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-05) 2017-10-010000-00-00NoNoCurrent
42806-349-094280603490990 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-09) 2017-10-010000-00-00NoNoCurrent