FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
69097-072
11-digit product format
690970072
Labeler code
69097
Product ID
69097-072_9c292b5a-2a09-4f01-b1fe-8652dd577542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA., Inc.
Application
ANDA207479
Marketing category
ANDA
Marketing start
2023-10-25
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
69097-072-12Bupropion Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-072BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CIPLA USA., INC.]1Current NDC, 1 package rows20231026_0abd64f7-5142-48f6-a487-3f5bdc3400de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN0abd64f7-5142-48f6-a487-3f5bdc3400de1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN0abd64f7-5142-48f6-a487-3f5bdc3400de1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0abd64f7-5142-48f6-a487-3f5bdc3400de1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD0abd64f7-5142-48f6-a487-3f5bdc3400de1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY0abd64f7-5142-48f6-a487-3f5bdc3400de1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY0abd64f7-5142-48f6-a487-3f5bdc3400de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69097-072-1269097007212500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-072-12) 2023-10-25NoNoCurrent