FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
58657-713
Requested package NDC
58657-713-50
11-digit product format
586570713
Labeler code
58657
Product ID
58657-713_edb47931-e2a7-4ee7-e053-2995a90a40b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA211020
Marketing category
ANDA
Marketing start
2019-01-28
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
2023-12-31
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 packagepackage58657-71358657-713-50DDiscontinued by firm2026-07-31

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
A211020-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28
A211020-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211020-001AB3
A211020-002AB3

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 22:54:322026-06A211020-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28a50c72e98297…
2026-08-01 22:54:322026-06A211020-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32019-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211020-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A211020-002AB31a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacka613cfd3-1aa1-49c5-b742-b105c97d73f12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.136f29fa-a859-4efb-8365-1382716d6f8f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
bupropion hydrochlorideBUPROPION HYDROCHLORIDERising Pharma Holdings, Inc.e4f4d3fa-ddf6-4125-8486-8157efc095c12026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.d087222e-c5e9-4c48-b27f-e2e2944379c82025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsaeb506f8-97c2-409a-aac9-5a73c840e8f32024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211020
application number: ANDA211020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-713-30EA - Each58657-7136f203d4b-1e04-4e64-8bdd-45ae1ad371de12022-03-09
58657-713-50EA - Each58657-71349b399c5-0952-4d20-9712-f87a7b5774be12022-03-09
58657-713-90EA - Each58657-71315306fc1-a19f-428e-8f4c-00cc79cdb7d112022-03-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-713-5058657071350500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-713-50) 2019-01-280000-00-00NoNoCurrent