FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1702
11-digit product format
713351702
Labeler code
71335
Product ID
71335-1702_9b7aad7e-214e-42a2-a5e8-f839b063282d
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
150 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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993518

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
71335-1702-1Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60108
71335-1702-2Bupropion HydrochlorideSR90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90108
71335-1702-3Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30108
71335-1702-4Bupropion HydrochlorideSR120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE120108
71335-1702-5Bupropion HydrochlorideSR45 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE45108
71335-1702-6Bupropion HydrochlorideSR180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE180108
71335-1702-7Bupropion HydrochlorideSR28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE28108
71335-1702-8Bupropion HydrochlorideSR56 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE56108
71335-1702-9Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1702-1EA - Each71335-1702adb15943-8f11-466b-9549-2a766313061a12022-10-06
71335-1702-3EA - Each71335-170290d71afa-1ebb-455e-9dcc-2c953aab2d1012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1702BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 9 package rows20240830_a72db723-df4b-4bf4-9bdc-05ae82058696.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNa72db723-df4b-4bf4-9bdc-05ae82058696108
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDa72db723-df4b-4bf4-9bdc-05ae82058696108
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYa72db723-df4b-4bf4-9bdc-05ae82058696108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1702-17133517020160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-1) 2020-09-160000-00-00NoNoCurrent
71335-1702-27133517020290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-2) 2020-11-200000-00-00NoNoCurrent
71335-1702-37133517020330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-3) 2020-10-060000-00-00NoNoCurrent
71335-1702-471335170204120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-4) 2024-04-040000-00-00NoNoCurrent
71335-1702-57133517020545 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-5) 2024-04-040000-00-00NoNoCurrent
71335-1702-671335170206180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-6) 2020-09-080000-00-00NoNoCurrent
71335-1702-77133517020728 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-7) 2024-04-040000-00-00NoNoCurrent
71335-1702-87133517020856 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-8) 2024-04-040000-00-00NoNoCurrent
71335-1702-971335170209100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1702-9) 2024-04-04NoNoCurrent