FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
70518-1229
11-digit product format
705181229
Labeler code
70518
Product ID
70518-1229_de1cf9ab-31f3-4638-e053-2995a90a61ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208652
Marketing category
ANDA
Marketing start
2018-05-25
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-1229DDiscontinued by firm2026-07-31
excluded packagepackage70518-122970518-1229-0DDiscontinued by firm2026-07-31
excluded packagepackage70518-122970518-1229-1DDiscontinued 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
A208652-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21
A208652-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208652-001AB3
A208652-002AB3

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 22:54:322026-06A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21a50c72e98297…
2026-08-01 22:54:322026-06A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208652-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A208652-002AB31a50c72e98297…

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 Hydrochloride (XL)BUPROPION HYDROCHLORIDEMullan Pharmaceutical Inc.75b1e027-4c5d-46e5-98ee-033e67bd411c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
Bupropion hydrochloride (XL)BUPROPION HYDROCHLORIDELannett Company Inc.15c4e95a-d203-4caf-b6c7-44792355cb762025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
Bupropion hydrochloride (XL)BUPROPION HYDROCHLORIDEVitruvias Therapeuticsf53704b2-3d3c-47e8-9fd6-a0f5240c05932025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652
BUPROPION HYDROCHLORIDE (XL)BUPROPION HYDROCHLORIDE (XL)Chartwell RX, LLC8d9779e7-300e-4720-8ba5-2272b2506cd92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208652
application number: ANDA208652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1229-07051812290030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1229-0) 2018-05-250000-00-00NoNoCurrent