Bupropion Hydrochloride XL

Product NDC
60687-793
Requested package NDC
60687-793-21
11-digit product format
606870793
Labeler code
60687
Product ID
60687-793_5a59c5f9-d4ea-737c-e063-6394a90ae605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090693
Marketing category
ANDA
Marketing start
2024-01-15
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090693-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06
A090693-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090693-001AB3
A090693-002AB3

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090693-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A090693-002AB3184e616aacf4f…
2026-08-18 06:07:402026-07A090693-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A090693-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090693-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090693-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090693-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090693-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090693-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090693-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090693-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090693-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090693-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090693-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090693-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090693-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090693-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090693-002AB3174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
60687-793-11Bupropion Hydrochloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE12
60687-793-21Bupropion Hydrochloride30 in 1 CARTONTABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-793-11EA - Each60687-793ef9ecc3b-b10e-40e2-b301-b77dede9052312024-04-05
60687-793-21EA - Each60687-7939950076c-e780-4e07-8698-7eadabf22ad212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-793BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20240130_8dab6d17-bf41-4a28-90db-b66959c0e143.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.bcbef1b4-a135-4231-bc65-7d0b335260e82026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEQuallent Pharmaceuticals Health LLC56df4e22-81ca-48a4-a8e2-0384484173552026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsaa3d3e5b-74a3-47f6-b9aa-d6e248e950e52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.740534d3-59b5-4938-8e38-16275a14438c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDELupin Pharmaceuticals, Inc.1af14d2e-c64d-44b7-a402-8869e8e306612026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDECoupler LLC512b0ed3-db7d-b273-e063-6394a90a25cc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions039d4368-c764-463a-b0cd-1cac702b8fb22026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions6902b252-dc69-4b3c-bad2-b6667a5f6d842026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENorthwind Health Company, LLCf2b30440-0e07-2670-e053-2995a90afa282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.458c8a67-4995-c772-e063-6394a90a1f8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.45789ff4-af5d-96b0-e063-6394a90a06442025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa0fdfc21-165a-43fa-9b3c-e48f3b8922502025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionseee88553-acff-4bdd-acd1-f39bcb6fcdca2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging8dab6d17-bf41-4a28-90db-b66959c0e1432025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
ndc (package): 60687-793-21
ndc (product): 60687-793
ndc11 (package): 60687079321
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAvPAK2f9c5162-a6c5-e362-e063-6294a90a198d2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.0e8b2109-8516-2d92-e063-6394a90a5d162025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN8dab6d17-bf41-4a28-90db-b66959c0e1432
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8dab6d17-bf41-4a28-90db-b66959c0e1432
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8dab6d17-bf41-4a28-90db-b66959c0e1432
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8dab6d17-bf41-4a28-90db-b66959c0e1432
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY8dab6d17-bf41-4a28-90db-b66959c0e1432
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8dab6d17-bf41-4a28-90db-b66959c0e1432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-793-216068707932130 BLISTER PACK in 1 CARTON (60687-793-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-793-11) 30 blister pack2024-01-15NoNoCurrent