FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
43598-753
11-digit product format
435980753
Labeler code
43598
Product ID
43598-753_1005fd33-b291-408a-8be3-6acaac39bebf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.
Application
ANDA205794
Marketing category
ANDA
Marketing start
2018-05-15
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
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
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
43598-753-60Bupropion Hydrochloride SR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-753-60EA - Each43598-753b482b34d-5d24-4cf1-a2d4-c9fd8c76640a12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-753BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY’S LABORATORIES INC.]9Current NDC, Legacy NDC, 1 package rows20241027_ad784c8e-7201-4336-a310-616e3e979ca4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNad784c8e-7201-4336-a310-616e3e979ca410
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNad784c8e-7201-4336-a310-616e3e979ca410
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNad784c8e-7201-4336-a310-616e3e979ca410
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDad784c8e-7201-4336-a310-616e3e979ca410
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDad784c8e-7201-4336-a310-616e3e979ca410
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDad784c8e-7201-4336-a310-616e3e979ca410
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYad784c8e-7201-4336-a310-616e3e979ca410
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYad784c8e-7201-4336-a310-616e3e979ca410
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYad784c8e-7201-4336-a310-616e3e979ca410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-753-604359807536060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-753-60) 2018-05-150000-00-00NoNoCurrent