Bupropion Hydrochloride

Product NDC
77771-144
11-digit product format
777710144
Labeler code
77771
Product ID
77771-144_3bf617e4-22ef-4237-b80b-24c4c1b1bfda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RADHA PHARMACEUTICALS, INC.
Application
ANDA207479
Marketing category
ANDA
Marketing start
2022-10-26
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
Brand name suffix
(XL)
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
77771-144-05Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5003
77771-144-30Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE303
77771-144-90Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-144-05EA - Each77771-144a555b6fb-d2d3-494a-9f9a-9d7f142c2b4112022-12-07
77771-144-30EA - Each77771-14480bf7f74-37a3-4a8f-bcc4-eb29d689813d12022-12-07
77771-144-90EA - Each77771-144629ba00e-f1f6-4586-8171-f01882f36ba612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-144BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [RADHA PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20241027_16a788ff-8bd5-4f70-a3fd-a89db019e435.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN16a788ff-8bd5-4f70-a3fd-a89db019e4353
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN16a788ff-8bd5-4f70-a3fd-a89db019e4353
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD16a788ff-8bd5-4f70-a3fd-a89db019e4353
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD16a788ff-8bd5-4f70-a3fd-a89db019e4353
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY16a788ff-8bd5-4f70-a3fd-a89db019e4353
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY16a788ff-8bd5-4f70-a3fd-a89db019e4353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
77771-144-0577771014405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-05) 2022-10-260000-00-00NoNoCurrent
77771-144-307777101443030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-30) 2022-10-260000-00-00NoNoCurrent
77771-144-907777101449090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-90) 2022-10-260000-00-00NoNoCurrent