FDA.reportPublic FDA data

bupropion Hydrochloride

Product NDC
69097-918
11-digit product format
690970918
Labeler code
69097
Product ID
69097-918_c1d5cac6-7ca2-4b55-90c3-5ef51df0a1ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CIPLA USA INC.,
Application
ANDA207389
Marketing category
ANDA
Marketing start
2018-05-26
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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687, 993691

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
69097-918-02bupropion Hydrochloride30 in 1 BOTTLETABLET306
69097-918-07bupropion Hydrochloride100 in 1 BOTTLETABLET1006
69097-918-15bupropion Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-918-07EA - Each69097-918e1527580-9628-4fc3-9949-3d4608af6c9012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-918BUPROPION HYDROCHLORIDE TABLET [CIPLA USA INC.,]6Current NDC, Legacy NDC, 3 package rows20230328_e4100232-a25d-4468-9057-af7e66205154.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNc1fa6fce-272b-4497-a958-177f0bafdfc78
993687bupropion hydrochloride 100 MG Oral TabletSCDc1fa6fce-272b-4497-a958-177f0bafdfc78
993687buPROPion HCl 100 MG Oral TabletPSNe4100232-a25d-4468-9057-af7e662051546
993691buPROPion HCl 75 MG Oral TabletPSNe4100232-a25d-4468-9057-af7e662051546
993687bupropion hydrochloride 100 MG Oral TabletSCDe4100232-a25d-4468-9057-af7e662051546
993691bupropion hydrochloride 75 MG Oral TabletSCDe4100232-a25d-4468-9057-af7e662051546
993691bupropion HCl 75 MG Oral TabletSYe4100232-a25d-4468-9057-af7e662051546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-918-026909709180230 TABLET in 1 BOTTLE (69097-918-02) 30 tablet2018-05-260000-00-00NoNoCurrent
69097-918-0769097091807100 TABLET in 1 BOTTLE (69097-918-07) 100 tablet2018-05-260000-00-00NoNoCurrent
69097-918-15690970918151000 TABLET in 1 BOTTLE (69097-918-15) 1000 tablet2018-05-260000-00-00NoNoCurrent