FDA.reportPublic FDA data

bupropion

Product NDC
68788-7283
Requested package NDC
68788-7283-8
11-digit product format
687887283
Labeler code
68788
Product ID
68788-7283_3970ec44-2c55-4b14-840c-d7454a7160a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
2022-12-31
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 packagepackage68788-728368788-7283-8DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202304-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202304-001AB1
A202304-002AB1
A202304-003AB1

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 22:54:322026-06A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202304-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-003AB11a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.850ac56a-ba50-4e61-b1ee-805e17735b5c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDENorthwind Health Company, LLCab6cd2ea-507c-35e5-e053-2a95a90ac5cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEProficient Rx LP909204fc-ff55-43d9-b9ee-e607ef60965e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7283-1EA - Each68788-728320f61dc6-293d-4633-9e11-6973321fabe712020-09-14
68788-7283-2EA - Each68788-72833850259a-d6ef-469c-80ad-101e837f8c5f12020-09-14
68788-7283-3EA - Each68788-7283bda20c28-c5a1-492e-bf44-812cc9d6a95612020-09-14
68788-7283-6EA - Each68788-7283d71a87b6-5082-4111-a8c1-cf2bca63adda12020-09-14
68788-7283-8EA - Each68788-7283aaa79341-cb88-44c6-9d8d-5c3c8844a88112020-09-14
68788-7283-9EA - Each68788-7283116b69d6-344c-4c51-87ed-d0382242997e12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7283-868788728308120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7283-8) 2019-10-170000-00-00NoNoCurrent