FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
70934-724
11-digit product format
709340724
Labeler code
70934
Product ID
70934-724_aa08018e-bddc-6218-e053-2995a90a686e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA208652
Marketing category
ANDA
Marketing start
2020-05-20
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-724-302023-01-30C16284748780-1f386c64a-2e52-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985
70934-724-902023-01-30C16284748780-1f386c64a-2e52-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-724-30Bupropion hydrochloride (XL)30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301
70934-724-90Bupropion hydrochloride (XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-724-30EA - Each70934-7242b621fbc-5525-471a-a7d7-cefca441c8f712022-11-07
70934-724-90EA - Each70934-72428a00042-9e92-4076-96e8-7d192cc5993b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-724BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 2 package rows20201031_aa0800f6-3234-4908-e053-2a95a90a3a77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaa0800f6-3234-4908-e053-2a95a90a3a771
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaa0800f6-3234-4908-e053-2a95a90a3a771
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaa0800f6-3234-4908-e053-2a95a90a3a771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-724-307093407243030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-724-30) 2020-06-150000-00-00NoNoCurrent
70934-724-907093407249090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-724-90) 2020-05-200000-00-00NoNoCurrent