FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE (XL)

Product NDC
62135-875
11-digit product format
621350875
Labeler code
62135
Product ID
62135-875_155edd5e-1f89-6a6c-e063-6394a90aacdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE (XL)
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA208652
Marketing category
ANDA
Marketing start
2017-08-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE (XL)
Listing expiration
2026-12-31

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
62135-875-30BUPROPION HYDROCHLORIDE (XL)30 in 1 PACKAGETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-875-30EA - Each62135-875ccedf08d-86a7-4221-82d3-6aad249d52a112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-875BUPROPION HYDROCHLORIDE (XL) TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240407_8d9779e7-300e-4720-8ba5-2272b2506cd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN8d9779e7-300e-4720-8ba5-2272b2506cd91
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8d9779e7-300e-4720-8ba5-2272b2506cd91
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8d9779e7-300e-4720-8ba5-2272b2506cd91
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8d9779e7-300e-4720-8ba5-2272b2506cd91
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY8d9779e7-300e-4720-8ba5-2272b2506cd91
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8d9779e7-300e-4720-8ba5-2272b2506cd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-875-306213508753030 TABLET, EXTENDED RELEASE in 1 PACKAGE (62135-875-30) 2024-03-28NoNoCurrent