FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
47335-737
11-digit product format
473350737
Labeler code
47335
Product ID
47335-737_b8e6ae63-c5d7-4481-b7b0-17e135670515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078866
Marketing category
ANDA
Marketing start
2020-03-01
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
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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-737-08Bupropion hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10016
47335-737-13Bupropion hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50016
47335-737-86Bupropion hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6016
47335-737-88Bupropion hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-737BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]16Current NDC, Legacy NDC, 4 package rows20241210_29848192-7de3-4c0d-a822-1268dcf128b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN29848192-7de3-4c0d-a822-1268dcf128b016
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN29848192-7de3-4c0d-a822-1268dcf128b016
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN29848192-7de3-4c0d-a822-1268dcf128b016
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD29848192-7de3-4c0d-a822-1268dcf128b016
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD29848192-7de3-4c0d-a822-1268dcf128b016
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD29848192-7de3-4c0d-a822-1268dcf128b016
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY29848192-7de3-4c0d-a822-1268dcf128b016
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY29848192-7de3-4c0d-a822-1268dcf128b016
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY29848192-7de3-4c0d-a822-1268dcf128b016
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY6d6ec7d4-e3f4-4ade-b76b-49a9bb6d61c54
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1b69c253-4740-44b0-be63-6c20834540b63
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1b69c253-4740-44b0-be63-6c20834540b63
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1b69c253-4740-44b0-be63-6c20834540b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-737-0847335073708100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-08) 2020-03-010000-00-00NoNoCurrent
47335-737-1347335073713500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-13) 2020-03-010000-00-00NoNoCurrent
47335-737-864733507378660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-86) 2020-03-010000-00-00NoNoCurrent
47335-737-8847335073788100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-88) 2020-03-010000-00-00NoNoCurrent