Bupropion Hydrochloride

Product NDC
42806-424
11-digit product format
428060424
Labeler code
42806
Product ID
42806-424_50036e03-a443-a430-e063-6394a90a72c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA211347
Marketing category
ANDA
Marketing start
2023-09-18
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211347-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16
A211347-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16
A211347-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211347-001AB1
A211347-002AB1
A211347-003AB1

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12018-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12018-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211347-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12018-10-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211347-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211347-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211347-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211347-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211347-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211347-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211347-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211347-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211347-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211347-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211347-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211347-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211347-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211347-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211347-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A211347-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211347-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211347-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211347-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211347-001AB118072bd15b7f6…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEEpic Pharma, LLCf8ad76a2-9f75-4660-973d-34402f314e9c2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347
ndc (product): 42806-424
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENorthwind Health Company, LLCf2b3939b-a410-6354-e053-2995a90ababb2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack500fc18d-93b4-47d5-a3f7-3f68822d83e82024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack634bc654-be95-4fea-b308-eed53269a1122024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack0574b84d-075f-410f-a8eb-86901e307ea22024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDESlate Run Pharmaceuticals, LLC7c4313fa-bb29-dd50-e053-2991aa0a30052024-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211347
application number: ANDA211347

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993503Internal RxNorm lookup
993518Internal RxNorm lookup
993536Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ad76a2-9f75-4660-973d-34402f314e9cAvailable 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
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
42806-424-01Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
42806-424-05Bupropion HydrochlorideSR500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
42806-424-60Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-424-01EA - Each42806-42498629e34-d667-4867-9bf2-a460e2fb5eec12025-01-14
42806-424-60EA - Each42806-424f9d0c59b-1af0-401b-8d73-f74b18b4754212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-424BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC]5Current NDC, 3 package rows20241204_f8ad76a2-9f75-4660-973d-34402f314e9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-424-0142806042401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01) 2023-09-18NoNoCurrent
42806-424-0542806042405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05) 2023-09-18NoNoCurrent
42806-424-604280604246060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60) 2023-09-18NoNoCurrent