FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
68788-4010
11-digit product format
687884010
Labeler code
68788
Product ID
68788-4010_069e6828-e599-4614-9645-9cf1382ac93e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA215568
Marketing category
ANDA
Marketing start
2025-09-04
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4010-1Bupropion hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
68788-4010-3Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
68788-4010-6Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
68788-4010-9Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4010-1EA - Each68788-4010cd1755b6-57f3-4cec-be7f-7c3643e64ff312025-11-13
68788-4010-3EA - Each68788-401037583b85-b203-4bab-bea7-0d0790665bcd12025-11-13
68788-4010-6EA - Each68788-4010b2f2c697-7d23-4fd3-93e7-6040058da38312025-11-13
68788-4010-9EA - Each68788-4010184ae1bf-9421-4684-8933-5fc6bb80053912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN069e6828-e599-4614-9645-9cf1382ac93e1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD069e6828-e599-4614-9645-9cf1382ac93e1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY069e6828-e599-4614-9645-9cf1382ac93e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4010-168788401001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4010-1) 2025-09-04NoNoCurrent
68788-4010-36878840100330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4010-3) 2025-09-04NoNoCurrent
68788-4010-66878840100660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4010-6) 2025-09-04NoNoCurrent
68788-4010-96878840100990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4010-9) 2025-09-04NoNoCurrent