Bupropion Hydrochloride

Product NDC
70436-059
11-digit product format
704360059
Labeler code
70436
Product ID
70436-059_1b0de43f-05c2-aed6-e063-6394a90ac5df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA211347
Marketing category
ANDA
Marketing start
2020-11-02
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
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2026-12-31

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 · 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
7c4313fa-bb29-dd50-e053-2991aa0a3005Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-059-01Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, EXTENDED RELEASE10017
70436-059-02Bupropion HydrochlorideSR500 in 1 BOTTLETABLET, EXTENDED RELEASE50017
70436-059-05Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, EXTENDED RELEASE6017
70436-059-22Bupropion HydrochlorideSR250 in 1 BOTTLETABLET, EXTENDED RELEASE25017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-059BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]17Current NDC, Legacy NDC, 4 package rows20240617_7c4313fa-bb29-dd50-e053-2991aa0a3005.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 · 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
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
ndc (product): 70436-059

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0574b84d-075f-410f-a8eb-86901e307ea2106
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0574b84d-075f-410f-a8eb-86901e307ea2106
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0574b84d-075f-410f-a8eb-86901e307ea2106
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN7c4313fa-bb29-dd50-e053-2991aa0a300517
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN7c4313fa-bb29-dd50-e053-2991aa0a300517
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN7c4313fa-bb29-dd50-e053-2991aa0a300517
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD7c4313fa-bb29-dd50-e053-2991aa0a300517
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7c4313fa-bb29-dd50-e053-2991aa0a300517
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD7c4313fa-bb29-dd50-e053-2991aa0a300517
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY7c4313fa-bb29-dd50-e053-2991aa0a300517
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY7c4313fa-bb29-dd50-e053-2991aa0a300517
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY7c4313fa-bb29-dd50-e053-2991aa0a300517
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf2b3939b-a410-6354-e053-2995a90ababb3
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf2b3939b-a410-6354-e053-2995a90ababb3
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf2b3939b-a410-6354-e053-2995a90ababb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-059-0170436005901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-01) 2020-11-020000-00-00NoNoCurrent
70436-059-0270436005902500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-02) 2020-11-020000-00-00NoNoCurrent
70436-059-057043600590560 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-05) 2020-11-020000-00-00NoNoCurrent
70436-059-2270436005922250 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-059-22) 2020-11-020000-00-00NoNoCurrent