FDA.reportPublic FDA data

Bupropion

Product NDC
54868-5927
11-digit product format
548685927
Labeler code
54868
Product ID
54868-5927_5157468f-8f49-4746-a2c2-91a2020537e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Physicians Total Care, Inc.
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-08-13
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5927-02019-09-24C16284748780-19350213a-4739-c013-e053-90daa90a139382f5292b-b113-4f10-9469-04386fa8e9d4
54868-5927-12019-09-24C16284748780-19350213a-4739-c013-e053-90daa90a139382f5292b-b113-4f10-9469-04386fa8e9d4
54868-5927-22019-09-24C16284748780-19350213a-4739-c013-e053-90daa90a139382f5292b-b113-4f10-9469-04386fa8e9d4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5927-0BupropionHydrochloride Extended Release (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE305
54868-5927-1BupropionHydrochloride Extended Release (XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE905
54868-5927-2BupropionHydrochloride Extended Release (XL)60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5927-0EA - Each54868-592783411b49-0450-4636-890d-921e2db5f1b812012-07-24
54868-5927-2EA - Each54868-5927722b9ec3-dd60-41e3-9765-da1c134f89a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5927BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5Legacy NDC, 3 package rows20100709_82f5292b-b113-4f10-9469-04386fa8e9d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54868-5927-05486859270030 in 1 BOTTLEHistorical
54868-5927-15486859270190 in 1 BOTTLEHistorical
54868-5927-25486859270260 in 1 BOTTLEHistorical