Bupropion hydrochloride (XL)

Product NDC
69680-157
11-digit product format
696800157
Labeler code
69680
Product ID
69680-157_c7d45984-a653-4be6-9b1c-986a553e4e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Vitruvias Therapeutics
Application
ANDA208652
Marketing category
ANDA
Marketing start
2023-04-10
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
2027-12-31
Current FDA listing
Yes

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208652-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A208652-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-08-21782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208652-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208652-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208652-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208652-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208652-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208652-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208652-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208652-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208652-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208652-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208652-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208652-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208652-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208652-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208652-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208652-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208652-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208652-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208652-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208652-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208652-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208652-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208652-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208652-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208652-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208652-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208652-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208652-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A208652-002AB31782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion hydrochloride (XL)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993541Internal RxNorm lookup
993557Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f53704b2-3d3c-47e8-9fd6-a0f5240c0593Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69680-157-30Bupropion hydrochloride (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE304
69680-157-90Bupropion hydrochloride (XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE904
69680-157-92Bupropion hydrochloride (XL)500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
69680-157-93Bupropion hydrochloride (XL)1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69680-157-90EA - Each69680-1578fc59c07-4c31-4061-b722-270cabc6206012025-05-14
69680-157-92EA - Each69680-157b110ab07-358d-4113-ad11-1936d37bd56112023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69680-157BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS]2Current NDC, 4 package rows20241020_f53704b2-3d3c-47e8-9fd6-a0f5240c0593.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 69680-157
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNf53704b2-3d3c-47e8-9fd6-a0f5240c05934
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNf53704b2-3d3c-47e8-9fd6-a0f5240c05934
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf53704b2-3d3c-47e8-9fd6-a0f5240c05934
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDf53704b2-3d3c-47e8-9fd6-a0f5240c05934
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYf53704b2-3d3c-47e8-9fd6-a0f5240c05934
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYf53704b2-3d3c-47e8-9fd6-a0f5240c05934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69680-157-306968001573030 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-30) 2023-04-10NoNoCurrent
69680-157-906968001579090 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-90) 2023-04-10NoNoCurrent
69680-157-9269680015792500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92) 2023-04-10NoNoCurrent
69680-157-93696800157931000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-93) 2023-04-10NoNoCurrent