FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
70010-127
11-digit product format
700100127
Labeler code
70010
Product ID
70010-127_4377481d-43ac-f347-e063-6394a90acc90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA218385
Marketing category
ANDA
Marketing start
2025-03-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

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
70010-127-03BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
70010-127-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5003
70010-127-06BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-127BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250331_61e9cbe3-8211-42f3-b68f-581f56651919.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN61e9cbe3-8211-42f3-b68f-581f566519193
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN61e9cbe3-8211-42f3-b68f-581f566519193
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN61e9cbe3-8211-42f3-b68f-581f566519193
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD61e9cbe3-8211-42f3-b68f-581f566519193
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD61e9cbe3-8211-42f3-b68f-581f566519193
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD61e9cbe3-8211-42f3-b68f-581f566519193
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY61e9cbe3-8211-42f3-b68f-581f566519193
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY61e9cbe3-8211-42f3-b68f-581f566519193
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY61e9cbe3-8211-42f3-b68f-581f566519193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-127-037001001270330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-03) 2025-03-31NoNoCurrent
70010-127-0570010012705500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-05) 2025-03-31NoNoCurrent
70010-127-067001001270660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-06) 2025-03-31NoNoCurrent