FDA.reportPublic FDA data

bupropion hydrochloride

Product NDC
43547-288
11-digit product format
435470288
Labeler code
43547
Product ID
43547-288_e8f3396b-251b-4218-9dd8-4ad0a0f8f2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Solco Healthcare US LLC
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bupropion hydrochloride
Brand name suffix
SR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-288-06bupropion hydrochlorideSR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6015
43547-288-09bupropion hydrochlorideSR90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9015
43547-288-10bupropion hydrochlorideSR100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10015
43547-288-50bupropion hydrochlorideSR500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-288-09EA - Each43547-28812e0aa6c-c36c-4b8c-9f2a-e19a2281a49212015-08-04
43547-288-10EA - Each43547-288d05b2176-2cc6-488a-b6cc-b84fdc98695c12016-04-04
43547-288-50EA - Each43547-28827235088-a04a-452c-b078-9cdfa115e8f812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-288BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]15Current NDC, Legacy NDC, 4 package rows20250511_39b2d509-1281-4464-9cf1-a94bbc18b84b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN39b2d509-1281-4464-9cf1-a94bbc18b84b15
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN39b2d509-1281-4464-9cf1-a94bbc18b84b15
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN39b2d509-1281-4464-9cf1-a94bbc18b84b15
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD39b2d509-1281-4464-9cf1-a94bbc18b84b15
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD39b2d509-1281-4464-9cf1-a94bbc18b84b15
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD39b2d509-1281-4464-9cf1-a94bbc18b84b15
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY39b2d509-1281-4464-9cf1-a94bbc18b84b15
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY39b2d509-1281-4464-9cf1-a94bbc18b84b15
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY39b2d509-1281-4464-9cf1-a94bbc18b84b15
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN850ac56a-ba50-4e61-b1ee-805e17735b5c1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD850ac56a-ba50-4e61-b1ee-805e17735b5c1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY850ac56a-ba50-4e61-b1ee-805e17735b5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-288-064354702880660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-06) 2014-11-010000-00-00NoNoCurrent
43547-288-094354702880990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-09) 2014-11-010000-00-00NoNoCurrent
43547-288-1043547028810100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-10) 2014-11-010000-00-00NoNoCurrent
43547-288-5043547028850500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-50) 2014-11-010000-00-00NoNoCurrent