Bupropion hydrochloride

Product NDC
0615-8601
11-digit product format
006158601
Labeler code
0615
Product ID
0615-8601_82d92152-92be-419f-a7a5-7b36b318ea1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA216800
Marketing category
ANDA
Marketing start
2023-05-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216800-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31
A216800-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31
A216800-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216800-001AB1
A216800-002AB1
A216800-003AB1

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12023-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12023-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216800-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12023-05-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216800-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216800-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216800-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216800-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216800-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216800-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216800-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216800-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216800-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216800-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216800-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216800-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216800-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216800-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A216800-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A216800-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216800-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216800-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216800-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216800-001AB118072bd15b7f6…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5604eb14-bab4-4f06-e063-6294a90a69202026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack350336bf-57b1-4d2f-bf25-956bb6023c072026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack5c111cf0-0199-4a4d-8138-81579af4c14d2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4c9a5dc3-bebe-431a-b550-ce46c6c6b01e2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion HCL ER(SR)BUPROPION HCL ER(SR)DriectRx50afb442-e7c6-d28c-e063-6294a90a2b7e2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.f69b322b-93ab-407a-bf25-fe13c6896ca62026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.6087100f-3ba4-412e-b08d-768d1dcdaf002026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.093c4a61-02d9-4b55-b612-569aa25d3f2a2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs1bd2ed35-35c5-464f-bf51-9dd4b42ee59a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
ndc (product): 0615-8601
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0aa86bd6-b37b-45f7-a837-b067e41184e92025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC38f52cec-9534-dab8-e063-6294a90a07042025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackc5d55b0c-8b81-476a-994e-1989e2a562552025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsbb63261f-ad18-4885-9ed7-e7dfde33e1712024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa724b3b6-f60e-4b88-8603-8141a32075da2024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216800
application number: ANDA216800

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 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
993503Internal RxNorm lookup
993518Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bd2ed35-35c5-464f-bf51-9dd4b42ee59aAvailable 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
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
0615-8601-39Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8601-390061586013930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8601-39) 2025-10-31NoNoCurrent