Bupropion Hydrochloride

Product NDC
45963-142
11-digit product format
459630142
Labeler code
45963
Product ID
45963-142_50d33e34-1a33-4595-b06a-4da2f7d7d518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077285
Marketing category
ANDA
Marketing start
2015-02-17
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
Listing expiration
2027-12-31

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-142-05Bupropion Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50035
45963-142-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3035
45963-142-90Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-142BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]33Current NDC, Legacy NDC, 3 package rows20240625_df923448-4f81-47af-8e55-f7359746b05f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNdf923448-4f81-47af-8e55-f7359746b05f35
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDdf923448-4f81-47af-8e55-f7359746b05f35
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYdf923448-4f81-47af-8e55-f7359746b05f35
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN9e2d9c1e-a1de-491d-8f64-34ae604196115
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD9e2d9c1e-a1de-491d-8f64-34ae604196115
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY9e2d9c1e-a1de-491d-8f64-34ae604196115
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN7d776748-e0eb-dc9c-e053-2991aa0a88222
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN637e89e5-8f6e-4392-8045-a778cb9ed1382
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD7d776748-e0eb-dc9c-e053-2991aa0a88222
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD637e89e5-8f6e-4392-8045-a778cb9ed1382
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY7d776748-e0eb-dc9c-e053-2991aa0a88222
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY637e89e5-8f6e-4392-8045-a778cb9ed1382
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1b4b326e-64a2-4e1c-b16c-9190f4be4bb91
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1b4b326e-64a2-4e1c-b16c-9190f4be4bb91
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1b4b326e-64a2-4e1c-b16c-9190f4be4bb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-142-0545963014205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05) 2015-05-190000-00-00NoNoCurrent
45963-142-304596301423030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30) 2015-02-170000-00-00NoNoCurrent
45963-142-904596301429090 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90) 2015-06-150000-00-00NoNoCurrent