FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
43598-656
11-digit product format
435980656
Labeler code
43598
Product ID
43598-656_dc27d1dd-5931-08dc-e053-2995a90a21f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr Reddys Laboratories Inc
Application
ANDA207479
Marketing category
ANDA
Marketing start
2017-04-12
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
Brand name suffix
(XL)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
43598-656-05Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5008
43598-656-30Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE308
43598-656-90Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-656-05EA - Each43598-6564dfa5b16-42c2-4fa8-a7eb-a63b73226c6012017-09-11
43598-656-30EA - Each43598-6567b903b5e-bc4c-4e53-b8c2-2a1e2c6bb93612017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-656BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DR REDDYS LABORATORIES INC]8Current NDC, Legacy NDC, 3 package rows20220409_d5469d64-5e74-4b7a-b4cd-551665f6adaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd5469d64-5e74-4b7a-b4cd-551665f6adaa8
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNd5469d64-5e74-4b7a-b4cd-551665f6adaa8
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd5469d64-5e74-4b7a-b4cd-551665f6adaa8
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDd5469d64-5e74-4b7a-b4cd-551665f6adaa8
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd5469d64-5e74-4b7a-b4cd-551665f6adaa8
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYd5469d64-5e74-4b7a-b4cd-551665f6adaa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-656-0543598065605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-05) 2017-04-120000-00-00NoNoCurrent
43598-656-304359806563030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-30) 2017-04-120000-00-00NoNoCurrent
43598-656-904359806569090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-90) 2017-04-120000-00-00NoNoCurrent