bupropion hydrochloride

Product NDC
0904-7465
11-digit product format
009047465
Labeler code
0904
Product ID
0904-7465_bc353d98-bf85-4efb-995a-bb3dfd28825c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202304
Marketing category
ANDA
Marketing start
2024-11-15
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202304-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202304-001AB1
A202304-002AB1
A202304-003AB1

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 UTC2026-02A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202304-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202304-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202304-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202304-001AB118072bd15b7f6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
ndc (product): 0904-7465
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.850ac56a-ba50-4e61-b1ee-805e17735b5c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDENorthwind Health Company, LLCab6cd2ea-507c-35e5-e053-2a95a90ac5cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEProficient Rx LP909204fc-ff55-43d9-b9ee-e607ef60965e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304

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 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
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
67b6bcf8-0e7c-4e74-ad72-54f1bd6e65adAvailable 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
0904-7465-61bupropion hydrochlorideSR1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
0904-7465-61bupropion hydrochlorideSR100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7465-61EA - Each0904-7465b0f40e43-7d7d-4eb2-aecd-d032fa05dcd612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7465BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20241116_67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad3
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN439a7e93-f578-434f-943f-4b93c35450f52
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD439a7e93-f578-434f-943f-4b93c35450f52
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY439a7e93-f578-434f-943f-4b93c35450f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7465-6100904746561100 BLISTER PACK in 1 CARTON (0904-7465-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2024-11-15NoNoCurrent