FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
70010-784
11-digit product format
700100784
Labeler code
70010
Product ID
70010-784_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
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
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 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
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
70010-784-03Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
70010-784-05Bupropion hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
70010-784-09Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-784-03EA - Each70010-78412792880-78cd-48ab-956d-de4de947a52d12024-05-16
70010-784-05EA - Each70010-7845acd8faa-a5c6-44e1-9b9c-468dad5231a712024-05-16
70010-784-09EA - Each70010-784bc084c20-bbd5-4839-84af-f0447d786dc312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-784BUPROPION 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 TabletPSNaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaf5b1cc8-f078-4a7b-b64a-4cb2de1e5721100
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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNc60855ca-4fa0-4004-ad19-4abb61100c432
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc60855ca-4fa0-4004-ad19-4abb61100c432
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYc60855ca-4fa0-4004-ad19-4abb61100c432
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 startMarketing endSampleExclude flagStatus
70010-784-037001007840330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-03) 2022-12-150000-00-00NoNoCurrent
70010-784-0570010078405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-05) 2022-12-150000-00-00NoNoCurrent
70010-784-097001007840990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-09) 2022-12-150000-00-00NoNoCurrent