Bupropion Hydrochloride SR

Product NDC
33261-449
11-digit product format
332610449
Labeler code
33261
Product ID
33261-449_06831b0d-ae6e-45d0-bd17-955ab16c31d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201331
Marketing category
ANDA
Marketing start
2012-05-15
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
2019-12-31
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-449-02Bupropion Hydrochloride SR(SR)120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1201
33261-449-60Bupropion Hydrochloride SR(SR)60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE601
33261-449-90Bupropion Hydrochloride SR(SR)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-449-02EA - Each33261-4491cb3f7eb-c76b-4946-8c8e-628f80aa1fb612015-10-02
33261-449-60EA - Each33261-449327b94be-16dc-43c7-8f9d-a9cad8303dee12015-10-02
33261-449-90EA - Each33261-44972c3415b-71d6-49b4-86b6-41a4c4f4400512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2BUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-449BUPROPION HYDROCHLORIDE SR (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_efae7a52-cd67-484c-a9b4-3edca3ec476e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNefae7a52-cd67-484c-a9b4-3edca3ec476e1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDefae7a52-cd67-484c-a9b4-3edca3ec476e1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYefae7a52-cd67-484c-a9b4-3edca3ec476e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-449-0233261044902120 in 1 BOTTLE, PLASTICHistorical
33261-449-603326104496060 in 1 BOTTLE, PLASTICHistorical
33261-449-903326104499090 in 1 BOTTLE, PLASTICHistorical