FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
69367-289
11-digit product format
693670289
Labeler code
69367
Product ID
69367-289_19bc8511-a58b-da1c-e063-6394a90a5111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-289-05Bupropion HydrochlorideXL500 in 1 BOTTLETABLET, EXTENDED RELEASE50012
69367-289-09Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-289BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 2 package rows20240606_c280efb9-b284-6a69-e053-2995a90a3035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNc280efb9-b284-6a69-e053-2995a90a303512
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNc280efb9-b284-6a69-e053-2995a90a303512
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc280efb9-b284-6a69-e053-2995a90a303512
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDc280efb9-b284-6a69-e053-2995a90a303512
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYc280efb9-b284-6a69-e053-2995a90a303512
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYc280efb9-b284-6a69-e053-2995a90a303512
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN2aabf040-16a6-b772-e063-6294a90afd701
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNed27c415-9f29-4789-9da4-4a14aaba95bd1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD2aabf040-16a6-b772-e063-6294a90afd701
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDed27c415-9f29-4789-9da4-4a14aaba95bd1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY2aabf040-16a6-b772-e063-6294a90afd701
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYed27c415-9f29-4789-9da4-4a14aaba95bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-289-0569367028905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-05) 2017-10-010000-00-00NoNoCurrent
69367-289-096936702890990 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-09) 2017-10-010000-00-00NoNoCurrent