FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
71335-2652
11-digit product format
713352652
Labeler code
71335
Product ID
71335-2652_f87d9697-16ab-4ea8-9cd8-b6e326407a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075491
Marketing category
ANDA
Marketing start
2024-04-25
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687

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
71335-2652-1BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
71335-2652-2BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
71335-2652-3BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1001
71335-2652-4BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901
71335-2652-5BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED1201
71335-2652-6BUPROPION HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED151
71335-2652-7BUPROPION HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2652-1EA - Each71335-265234fc0437-7340-433e-bd3a-71121f65f50712026-05-22
71335-2652-2EA - Each71335-2652bc07df47-3d8d-4e99-af6a-c4ea6950157212026-05-22
71335-2652-3EA - Each71335-2652b03b81da-8839-4beb-91c5-1b3a7dae73ff12026-05-22
71335-2652-4EA - Each71335-26520a221004-1981-451b-bfa1-796238afe09d12026-05-22
71335-2652-5EA - Each71335-265237aeb4ad-0f13-4e40-9ffc-17dcda23d1c812026-05-22
71335-2652-6EA - Each71335-265248f136e3-bcdb-46de-a0dd-7ecbcb89c12512026-05-22
71335-2652-7EA - Each71335-26523ad8c1c5-0670-4c6e-8162-506b653ce7db12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN9a3b97be-afa3-49e6-962f-662b6807e6071
993687bupropion hydrochloride 100 MG Oral TabletSCD9a3b97be-afa3-49e6-962f-662b6807e6071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2652-17133526520160 TABLET, FILM COATED in 1 BOTTLE (71335-2652-1) 2025-06-03NoNoHistorical
71335-2652-27133526520230 TABLET, FILM COATED in 1 BOTTLE (71335-2652-2) 2025-06-03NoNoHistorical
71335-2652-371335265203100 TABLET, FILM COATED in 1 BOTTLE (71335-2652-3) 2025-06-03NoNoHistorical
71335-2652-47133526520490 TABLET, FILM COATED in 1 BOTTLE (71335-2652-4) 2025-06-03NoNoHistorical
71335-2652-571335265205120 TABLET, FILM COATED in 1 BOTTLE (71335-2652-5) 2025-06-03NoNoHistorical
71335-2652-67133526520615 TABLET, FILM COATED in 1 BOTTLE (71335-2652-6) 2025-06-03NoNoHistorical
71335-2652-77133526520721 TABLET, FILM COATED in 1 BOTTLE (71335-2652-7) 2025-06-03NoNoHistorical