BUPROPION HYDROCHLORIDE

Product NDC
33261-627
11-digit product format
332610627
Labeler code
33261
Product ID
33261-627_9e647b64-0405-4e32-97bd-0edb09854911
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077284
Marketing category
ANDA
Marketing start
2007-06-12
Marketing end
0000-00-00
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
E
Listing certified through
2018-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
33261-627-302020-01-31C16284748780-19d75b9cf-f1b5-f424-e053-dadaa90a57ceBupropion Hydrochloride Extended-Release Tablets USP (XL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-627-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-627-30EA - Each33261-6279de9756d-18b1-431d-a064-dbbb70b78cc312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-627BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140102_0bff4522-330e-4f75-929f-5e9f0d75a33f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN0bff4522-330e-4f75-929f-5e9f0d75a33f1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN0bff4522-330e-4f75-929f-5e9f0d75a33f1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0bff4522-330e-4f75-929f-5e9f0d75a33f1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD0bff4522-330e-4f75-929f-5e9f0d75a33f1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY0bff4522-330e-4f75-929f-5e9f0d75a33f1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY0bff4522-330e-4f75-929f-5e9f0d75a33f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-627-303326106273030 in 1 BOTTLE, PLASTICHistorical