FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
63629-7820
Requested package NDC
63629-7820-5
11-digit product format
636297820
Labeler code
63629
Product ID
63629-7820_463fd90a-8ffa-45a0-95b2-0c70f9b8c591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207224
Marketing category
ANDA
Marketing start
2017-10-01
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
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 packagepackage63629-782063629-7820-5IInactivated 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
A207224-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-06-30
A207224-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207224-001AB3
A207224-002AB3

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 22:54:322026-06A207224-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-06-30a50c72e98297…
2026-08-01 22:54:322026-06A207224-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207224-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A207224-002AB31a50c72e98297…

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 Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.ed27c415-9f29-4789-9da4-4a14aaba95bd2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207224
application number: ANDA207224
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2aabf040-16a6-b772-e063-6294a90afd702025-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207224
application number: ANDA207224
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEWestminster Pharmaceuticals, LLCc280efb9-b284-6a69-e053-2995a90a30352024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207224
application number: ANDA207224
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LP5e568bb5-542a-4395-a21e-dc64281d694e2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207224
application number: ANDA207224
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEEpic Pharma, LLC178c7129-a752-4ad9-ac82-4473e23bbacc2021-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207224
application number: ANDA207224

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
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
63629-7820-12024-01-30C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-22024-01-30C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-32024-01-30C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-42024-01-30C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-52024-01-30C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-12022-02-16C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-22022-02-16C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-12020-01-31C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985
63629-7820-22020-01-31C16284748780-19d75b9d0-1d20-f424-e053-dadaa90a57ceThese 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 (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7820-1Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE302
63629-7820-2Bupropion HydrochlorideXL60 in 1 BOTTLETABLET, EXTENDED RELEASE602
63629-7820-3Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE902
63629-7820-4Bupropion HydrochlorideXL120 in 1 BOTTLETABLET, EXTENDED RELEASE1202
63629-7820-5Bupropion HydrochlorideXL14 in 1 BOTTLETABLET, EXTENDED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7820BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2Legacy NDC, 5 package rows20220217_463fd90a-8ffa-45a0-95b2-0c70f9b8c591.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN463fd90a-8ffa-45a0-95b2-0c70f9b8c5912
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD463fd90a-8ffa-45a0-95b2-0c70f9b8c5912
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY463fd90a-8ffa-45a0-95b2-0c70f9b8c5912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7820-56362978200514 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7820-5) 2022-02-090000-00-00NoNoCurrent