FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1866
11-digit product format
713351866
Labeler code
71335
Product ID
71335-1866_6e0637b4-c749-42c9-83c2-259d306d173c
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
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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503

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
71335-1866-1Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE60105
71335-1866-2Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE90105
71335-1866-3Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE30105
71335-1866-4Bupropion HydrochlorideSR45 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE45105
71335-1866-5Bupropion HydrochlorideSR28 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE28105
71335-1866-6Bupropion HydrochlorideSR120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1866-1EA - Each71335-18661c9651e3-a76f-4d85-ac6c-53f15eb8832a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1866BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 6 package rows20240726_21be6b3b-add3-43e7-af93-30350aefc89e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN21be6b3b-add3-43e7-af93-30350aefc89e105
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD21be6b3b-add3-43e7-af93-30350aefc89e105
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY21be6b3b-add3-43e7-af93-30350aefc89e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1866-17133518660160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-1) 2021-06-210000-00-00NoNoCurrent
71335-1866-27133518660290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-2) 2024-07-170000-00-00NoNoCurrent
71335-1866-37133518660330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-3) 2021-09-160000-00-00NoNoCurrent
71335-1866-47133518660445 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-4) 2024-07-170000-00-00NoNoCurrent
71335-1866-57133518660528 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-5) 2024-07-170000-00-00NoNoCurrent
71335-1866-671335186606120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-1866-6) 2022-09-060000-00-00NoNoCurrent