FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1984
11-digit product format
713351984
Labeler code
71335
Product ID
71335-1984_5ebb33d8-62a9-496a-8205-40b77db9538f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205794
Marketing category
ANDA
Marketing start
2018-04-20
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
SR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993536

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
71335-1984-1Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE60105
71335-1984-2Bupropion HydrochlorideSR180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE180105
71335-1984-3Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE30105
71335-1984-4Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE90105
71335-1984-5Bupropion HydrochlorideSR120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE120105
71335-1984-6Bupropion HydrochlorideSR28 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE28105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1984BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 6 package rows20240726_6701af43-bf7d-45c4-a331-a18d16bd68f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN6701af43-bf7d-45c4-a331-a18d16bd68f7105
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD6701af43-bf7d-45c4-a331-a18d16bd68f7105
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY6701af43-bf7d-45c4-a331-a18d16bd68f7105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1984-17133519840160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-1) 2022-01-270000-00-00NoNoCurrent
71335-1984-271335198402180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-2) 2024-07-180000-00-00NoNoCurrent
71335-1984-37133519840330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-3) 2022-04-060000-00-00NoNoCurrent
71335-1984-47133519840490 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-4) 2024-07-180000-00-00NoNoCurrent
71335-1984-571335198405120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-5) 2024-07-180000-00-00NoNoCurrent
71335-1984-67133519840628 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1984-6) 2024-07-180000-00-00NoNoCurrent