FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-1150
11-digit product format
500901150
Labeler code
50090
Product ID
50090-1150_f3c02405-f0db-47fe-b943-fa20fdc1f432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079094
Marketing category
ANDA
Marketing start
2009-06-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079094-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB2RS2009-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A079094-001AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079094-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB2RS2009-03-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079094-001AB21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEActavis Pharma, Inc.a591e33a-52f0-41c8-a00b-4a1afcc3dc4c2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079094
application number: ANDA079094
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEA-S Medication Solutionsdfb45438-1116-48f2-9bfe-776ebbf1e1192023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079094
application number: ANDA079094
ndc (product): 50090-1150

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1801289Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfb45438-1116-48f2-9bfe-776ebbf1e119Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1150-0Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6018
50090-1150-1Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1150-0EA - Each50090-115096c3cd20-2c27-43ed-92af-ec3c8f99cbab12018-11-06
50090-1150-1EA - Each50090-1150f354b0d4-44b9-49d2-bea2-b22817e7689712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1150BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20231210_dfb45438-1116-48f2-9bfe-776ebbf1e119.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSNdfb45438-1116-48f2-9bfe-776ebbf1e11918
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDdfb45438-1116-48f2-9bfe-776ebbf1e11918
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSYdfb45438-1116-48f2-9bfe-776ebbf1e11918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1150-05009011500060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-1150-0) 2014-11-280000-00-00NoNoCurrent
50090-1150-15009011500130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1150-1) 2014-11-280000-00-00NoNoCurrent