FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
55700-820
11-digit product format
557000820
Labeler code
55700
Product ID
55700-820_56942110-9635-4106-a616-e227284026ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA210497
Marketing category
ANDA
Marketing start
2019-11-22
Marketing end
2026-08-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
55700-820-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE305
55700-820-90BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-820BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]5Current NDC, Legacy NDC, 2 package rows20241220_a225dbbb-86f0-4547-a1c8-68eb64cd6892.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa225dbbb-86f0-4547-a1c8-68eb64cd68925
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa225dbbb-86f0-4547-a1c8-68eb64cd68925
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa225dbbb-86f0-4547-a1c8-68eb64cd68925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-820-305570008203030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-820-30) 2019-11-222026-08-31NoNoCurrent
55700-820-905570008209090 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-820-90) 2020-11-120000-00-00NoNoCurrent