FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
46708-127
11-digit product format
467080127
Labeler code
46708
Product ID
46708-127_b09bdaa7-0871-4741-b5cd-dd30d683613c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA203013
Marketing category
ANDA
Marketing start
2018-06-18
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687, 993691

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
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-127-312023-02-01C16284748780-1f386c649-a2d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
46708-127-712023-02-01C16284748780-1f386c649-a2d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
46708-127-312023-01-30C16284748780-1f386c649-a2d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
46708-127-712023-01-30C16284748780-1f386c649-a2d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-127-31Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
46708-127-71Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-127BUPROPION HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20240111_ef0bb8f2-7710-4236-8b47-57b74c8bca3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNef0bb8f2-7710-4236-8b47-57b74c8bca3e4
993691buPROPion HCl 75 MG Oral TabletPSNef0bb8f2-7710-4236-8b47-57b74c8bca3e4
993687bupropion hydrochloride 100 MG Oral TabletSCDef0bb8f2-7710-4236-8b47-57b74c8bca3e4
993691bupropion hydrochloride 75 MG Oral TabletSCDef0bb8f2-7710-4236-8b47-57b74c8bca3e4
993691bupropion HCl 75 MG Oral TabletSYef0bb8f2-7710-4236-8b47-57b74c8bca3e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-127-3146708012731100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31) 2018-06-180000-00-00NoNoCurrent
46708-127-7146708012771500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71) 2018-06-180000-00-00NoNoCurrent