FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
53002-2495
Requested package NDC
53002-2495-3
11-digit product format
530022495
Labeler code
53002
Product ID
53002-2495_3005e3ea-dec5-4fb2-ad9d-8f20a1465d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208652
Marketing category
ANDA
Marketing start
2018-01-08
Marketing end
0000-00-00
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
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 packagepackage53002-249553002-2495-3IInactivated by FDA2026-07-31

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

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2495-02023-01-30C16284748780-1f386c64a-2699-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985
53002-2495-32023-01-30C16284748780-1f386c64a-2699-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL). BUPROPION HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2495-0Bupropion hydrochloride (XL)100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
53002-2495-3Bupropion hydrochloride (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2495BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20201222_b4d20e09-2952-413d-b3f8-4abb4ddf2cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2495-35300224950330 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-2495-3) 2020-01-010000-00-00NoNoCurrent