FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
16729-443
11-digit product format
167290443
Labeler code
16729
Product ID
16729-443_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
2018-11-08
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
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 HYDROCHLORIDE150 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
16729-443-10BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
16729-443-15BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE9013
16729-443-16BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-443-10EA - Each16729-443a559fd11-0424-47db-bdaf-54cf5c5a775512018-12-13
16729-443-15EA - Each16729-443873ab4be-00e5-4ebc-bac3-6cb53df7271c12018-12-13
16729-443-16EA - Each16729-44327998e18-e690-4de4-84cf-2033787e96f812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-443BUPROPION 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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN080853c0-fcab-4645-9ddc-4946e895ac5f22
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD080853c0-fcab-4645-9ddc-4946e895ac5f22
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY080853c0-fcab-4645-9ddc-4946e895ac5f22
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 TabletPSNae3bcdf7-d7f3-4f07-8113-af08af20a0d415
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDae3bcdf7-d7f3-4f07-8113-af08af20a0d415
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYae3bcdf7-d7f3-4f07-8113-af08af20a0d415
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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN7c46d95a-26f6-4364-8197-9e564e3405f212
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7c46d95a-26f6-4364-8197-9e564e3405f212
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY7c46d95a-26f6-4364-8197-9e564e3405f212
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN77b78d35-40f5-4713-8468-aa09a6c2925d9
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD77b78d35-40f5-4713-8468-aa09a6c2925d9
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY77b78d35-40f5-4713-8468-aa09a6c2925d9
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN42e228a2-25b3-44a6-8da7-6616ca44ac7f7
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD42e228a2-25b3-44a6-8da7-6616ca44ac7f7
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY42e228a2-25b3-44a6-8da7-6616ca44ac7f7
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNf8af7829-8b61-6785-e053-6294a90af0522
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNdf6093eb-2067-595f-e053-2995a90a5a6d2
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd99d21b3-090d-4c4b-b152-30ccb9f46c402
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd21a792a-4556-bcc0-e053-2a95a90a33912
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN42201f4a-8856-4499-8bc3-d18612b1ec342
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf8af7829-8b61-6785-e053-6294a90af0522
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD42201f4a-8856-4499-8bc3-d18612b1ec342
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd21a792a-4556-bcc0-e053-2a95a90a33912
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd99d21b3-090d-4c4b-b152-30ccb9f46c402
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDdf6093eb-2067-595f-e053-2995a90a5a6d2
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYf8af7829-8b61-6785-e053-6294a90af0522
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY42201f4a-8856-4499-8bc3-d18612b1ec342
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd21a792a-4556-bcc0-e053-2a95a90a33912
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd99d21b3-090d-4c4b-b152-30ccb9f46c402
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYdf6093eb-2067-595f-e053-2995a90a5a6d2
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN9af0fadd-0ef9-2317-e053-2a95a90a9a881
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN29a6c6e3-f30f-6541-e063-6394a90ae11d1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD29a6c6e3-f30f-6541-e063-6394a90ae11d1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9af0fadd-0ef9-2317-e053-2a95a90a9a881
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY9af0fadd-0ef9-2317-e053-2a95a90a9a881
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY29a6c6e3-f30f-6541-e063-6394a90ae11d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-443-101672904431030 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-10) 2018-11-080000-00-00NoNoCurrent
16729-443-151672904431590 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-15) 2018-11-080000-00-00NoNoCurrent
16729-443-1616729044316500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-16) 2018-11-080000-00-00NoNoCurrent