FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
70010-785
11-digit product format
700100785
Labeler code
70010
Product ID
70010-785_4dc0e5b6-865c-6e62-e063-6394a90a6231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA215568
Marketing category
ANDA
Marketing start
2022-12-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion hydrochloride
Listing expiration
2027-12-31

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
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
70010-785-03Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
70010-785-05Bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
70010-785-09Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-785-03EA - Each70010-785d2100023-4038-4786-8975-edb2f34be28712024-05-16
70010-785-05EA - Each70010-7857c32561f-86d2-4951-8d6d-e38878c14c0112024-05-16
70010-785-09EA - Each70010-785d91a7553-b4d7-4d3f-8936-561154846b9812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-785BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 3 package rows20240704_d9eb0939-63c1-48c4-a444-a899d7924d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd9eb0939-63c1-48c4-a444-a899d7924d0610
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNd9eb0939-63c1-48c4-a444-a899d7924d0610
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd9eb0939-63c1-48c4-a444-a899d7924d0610
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDd9eb0939-63c1-48c4-a444-a899d7924d0610
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd9eb0939-63c1-48c4-a444-a899d7924d0610
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYd9eb0939-63c1-48c4-a444-a899d7924d0610
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1724f474-d6ab-46af-940f-7f874d4ff7fc1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN487271f1-c956-086a-e063-6394a90a2dc71
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1724f474-d6ab-46af-940f-7f874d4ff7fc1
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD487271f1-c956-086a-e063-6394a90a2dc71
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1724f474-d6ab-46af-940f-7f874d4ff7fc1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY487271f1-c956-086a-e063-6394a90a2dc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-785-037001007850330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-785-03) 2022-12-150000-00-00NoNoCurrent
70010-785-0570010078505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-785-05) 2022-12-150000-00-00NoNoCurrent
70010-785-097001007850990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-785-09) 2022-12-150000-00-00NoNoCurrent