FDA.reportPublic FDA data

bupropion hydrochloride

Product NDC
16571-862
11-digit product format
165710862
Labeler code
16571
Product ID
16571-862_fe42636a-ae04-43be-b032-8973bbdde7d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA211020
Marketing category
ANDA
Marketing start
2022-08-01
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bupropion hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
16571-862-03bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE304
16571-862-09bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE904
16571-862-10bupropion hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
16571-862-12bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1204
16571-862-50bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-862-03EA - Each16571-8624f155186-d6ec-4160-b9a7-51943eb49e8512022-08-04
16571-862-09EA - Each16571-862b901f519-9729-4670-b6e8-193a370120ff12022-08-04
16571-862-12EA - Each16571-862d7f0faf3-7cab-4a68-96f1-08e032461e4912024-08-12
16571-862-50EA - Each16571-8628d87f2f8-d9de-4c07-be6f-b2b176658df712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-862BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 5 package rows20241114_e4f4d3fa-ddf6-4125-8486-8157efc095c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNe4f4d3fa-ddf6-4125-8486-8157efc095c14
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNe4f4d3fa-ddf6-4125-8486-8157efc095c14
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDe4f4d3fa-ddf6-4125-8486-8157efc095c14
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDe4f4d3fa-ddf6-4125-8486-8157efc095c14
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYe4f4d3fa-ddf6-4125-8486-8157efc095c14
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYe4f4d3fa-ddf6-4125-8486-8157efc095c14
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNaeb506f8-97c2-409a-aac9-5a73c840e8f32
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDaeb506f8-97c2-409a-aac9-5a73c840e8f32
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYaeb506f8-97c2-409a-aac9-5a73c840e8f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-862-031657108620330 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-03) 2022-08-010000-00-00NoNoCurrent
16571-862-091657108620990 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-09) 2022-08-010000-00-00NoNoCurrent
16571-862-10165710862101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-10) 2022-08-010000-00-00NoNoCurrent
16571-862-1216571086212120 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-12) 2024-06-03NoNoCurrent
16571-862-5016571086250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-862-50) 2022-08-010000-00-00NoNoCurrent