FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
10370-101
11-digit product format
103700101
Labeler code
10370
Product ID
10370-101_a9a1f889-378e-4569-be40-a816d914ec6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA077284
Marketing category
ANDA
Marketing start
2007-06-12
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
2023-12-31
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
10370-101-032022-09-23C16284748780-1e4f33bdf-9d23-d8a0-e053-dadaa90a6e4ea5ddc0dc-c176-4705-a9a0-e4ecaf1f5667
10370-101-502022-09-23C16284748780-1e4f33bdf-9d23-d8a0-e053-dadaa90a6e4ea5ddc0dc-c176-4705-a9a0-e4ecaf1f5667
10370-101-032022-07-29C16284748780-1e4f33bdf-9d23-d8a0-e053-dadaa90a6e4ea5ddc0dc-c176-4705-a9a0-e4ecaf1f5667
10370-101-502022-07-29C16284748780-1e4f33bdf-9d23-d8a0-e053-dadaa90a6e4ea5ddc0dc-c176-4705-a9a0-e4ecaf1f5667

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-101-00EA - Each10370-1017f0c988c-015b-4678-8033-4c04cef555c712012-07-24
10370-101-03EA - Each10370-101b6ea8814-2db3-4e3b-a9a3-470b92f1d3ba12012-07-24
10370-101-50EA - Each10370-101eac28bc7-b515-4a18-a8ba-7acc53f0914812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]21
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA 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
ALCOHOLINACTIVE INGREDIENT3K9958V90MBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA 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 CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA 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
POVIDONEINACTIVE INGREDIENTFZ989GH94EBUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUDEPRION (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [STAT RX USA 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
10370-101BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]37Legacy NDC20231208_a5ddc0dc-c176-4705-a9a0-e4ecaf1f5667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN93df2f0a-a343-95cf-e053-2a95a90aaeb34
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD93df2f0a-a343-95cf-e053-2a95a90aaeb34
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY93df2f0a-a343-95cf-e053-2a95a90aaeb34
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN83fa3e3f-29b9-4aae-9e7b-9175386df1442
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD83fa3e3f-29b9-4aae-9e7b-9175386df1442
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY83fa3e3f-29b9-4aae-9e7b-9175386df1442
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN0bff4522-330e-4f75-929f-5e9f0d75a33f1
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN5a45c22c-dd13-5bd3-e053-2991aa0aaf921
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
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5a45c22c-dd13-5bd3-e053-2991aa0aaf921
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
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY5a45c22c-dd13-5bd3-e053-2991aa0aaf921
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-101-031037001010330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-101-03) 2007-06-120000-00-00NoNoCurrent
10370-101-5010370010150500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-101-50) 2007-06-120000-00-00NoNoCurrent