FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
63629-2138
11-digit product format
636292138
Labeler code
63629
Product ID
63629-2138_7e67f0e9-c8f1-40fd-b9cd-c08ca8f3f718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077284
Marketing category
ANDA
Marketing start
2007-06-12
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
Rxcui993557

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
63629-2138-1Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE500104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2138-1EA - Each63629-2138e4657976-0451-4e11-9527-baaade8b89af12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2138BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20231130_bd3f1706-e6e0-4db1-b09e-5e718976766a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNbd3f1706-e6e0-4db1-b09e-5e718976766a104
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDbd3f1706-e6e0-4db1-b09e-5e718976766a104
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYbd3f1706-e6e0-4db1-b09e-5e718976766a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2138-163629213801500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-2138-1) 2007-06-120000-00-00NoNoCurrent