FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
70518-3787
11-digit product format
705183787
Labeler code
70518
Product ID
70518-3787_3c571320-469c-2a26-e063-6294a90a0877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205794
Marketing category
ANDA
Marketing start
2023-07-12
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
Brand name suffix
SR
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
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
70518-3787-0Bupropion HydrochlorideSR30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE306
70518-3787-1Bupropion HydrochlorideSR30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3787BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, 2 package rows20241127_c76f2f9f-3999-4bdd-8ec3-e0066318d378.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNc76f2f9f-3999-4bdd-8ec3-e0066318d3786
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDc76f2f9f-3999-4bdd-8ec3-e0066318d3786
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYc76f2f9f-3999-4bdd-8ec3-e0066318d3786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3787-07051837870030 in 1 BLISTER PACKHistorical
70518-3787-17051837870130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-3787-1) 2025-08-14NoNoHistorical