FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
70518-4093
11-digit product format
705184093
Labeler code
70518
Product ID
70518-4093_3fa40592-575b-111b-e063-6294a90a6466
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216800
Marketing category
ANDA
Marketing start
2024-06-04
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
Rxcui993503

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
70518-4093-0Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4093BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240606_0aa86bd6-b37b-45f7-a837-b067e41184e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN0aa86bd6-b37b-45f7-a837-b067e41184e93
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD0aa86bd6-b37b-45f7-a837-b067e41184e93
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY0aa86bd6-b37b-45f7-a837-b067e41184e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4093-07051840930030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4093-0) 2024-06-04NoNoCurrent