FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
68788-7221
Requested package NDC
68788-7221-3
11-digit product format
687887221
Labeler code
68788
Product ID
68788-7221_5780b8e1-58c3-4486-b0d6-64684e673ec5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077285
Marketing category
ANDA
Marketing start
2018-07-26
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-722168788-7221-3DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077285-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26
A077285-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077285-001AB3
A077285-002AB3

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 22:54:322026-06A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26a50c72e98297…
2026-08-01 22:54:322026-06A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077285-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A077285-002AB31a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEActavis Pharma, Inc.df923448-4f81-47af-8e55-f7359746b05f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEHAWAII REPACK, INC.b4a1d3b8-afcf-47e3-96d3-469d8f408a312025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAsclemed USA, Inc.637e89e5-8f6e-4392-8045-a778cb9ed1382025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LP9e2d9c1e-a1de-491d-8f64-34ae604196112022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7221-36878872210330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7221-3) 2018-07-260000-00-00NoNoCurrent