FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
16729-444
11-digit product format
167290444
Labeler code
16729
Product ID
16729-444_4092a3ea-403d-7a91-e063-6394a90a8ddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA210497
Marketing category
ANDA
Marketing start
2019-03-25
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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
16729-444-10BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
16729-444-15BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE9013
16729-444-16BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-444-10EA - Each16729-444ac1f1954-d55b-41ef-bd19-fd0a813db27012018-12-13
16729-444-15EA - Each16729-4445eae8fd8-911f-4e61-a0cb-2a42e346fd7f12022-04-06
16729-444-16EA - Each16729-444533d072c-849e-4f4f-ac43-6e43a244b26712018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-444BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 3 package rows20241127_34686e9d-c106-4276-8b47-7460cca8860e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN82bcdd72-9146-4c8d-a8aa-f92015864605103
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD82bcdd72-9146-4c8d-a8aa-f92015864605103
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY82bcdd72-9146-4c8d-a8aa-f92015864605103
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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN34686e9d-c106-4276-8b47-7460cca8860e13
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN34686e9d-c106-4276-8b47-7460cca8860e13
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD34686e9d-c106-4276-8b47-7460cca8860e13
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD34686e9d-c106-4276-8b47-7460cca8860e13
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY34686e9d-c106-4276-8b47-7460cca8860e13
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY34686e9d-c106-4276-8b47-7460cca8860e13
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa18b5460-fcbb-42dd-8b87-197d11a089286
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa18b5460-fcbb-42dd-8b87-197d11a089286
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa18b5460-fcbb-42dd-8b87-197d11a089286
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN5dec4414-5595-46c9-ada9-3fbe981520405
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa225dbbb-86f0-4547-a1c8-68eb64cd68925
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa225dbbb-86f0-4547-a1c8-68eb64cd68925
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD5dec4414-5595-46c9-ada9-3fbe981520405
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY5dec4414-5595-46c9-ada9-3fbe981520405
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa225dbbb-86f0-4547-a1c8-68eb64cd68925
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN9dbfa18a-bf47-47ce-a213-e092f61768bb2
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNee2842c3-65e3-3904-e053-2a95a90aabff2
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN5d40e301-7e06-4ecd-b7c6-3d7ac6a134d22
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD9dbfa18a-bf47-47ce-a213-e092f61768bb2
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD5d40e301-7e06-4ecd-b7c6-3d7ac6a134d22
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDee2842c3-65e3-3904-e053-2a95a90aabff2
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY9dbfa18a-bf47-47ce-a213-e092f61768bb2
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY5d40e301-7e06-4ecd-b7c6-3d7ac6a134d22
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYee2842c3-65e3-3904-e053-2a95a90aabff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-444-101672904441030 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10) 2019-03-250000-00-00NoNoCurrent
16729-444-151672904441590 in 1 BOTTLEHistorical
16729-444-1616729044416500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16) 2019-03-250000-00-00NoNoCurrent