Home NDC 0615-8581-39 BUPROPION HYDROCHLORIDE
Product NDC 0615-8581
Requested package NDC 0615-8581-39
11-digit product format 006158581
Labeler code 0615
Product ID 0615-8581_3304dc5d-ef92-4f13-ad33-8ad7ed92e058
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPROPION HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA075491
Marketing category ANDA
Marketing start 2024-04-25
Substance BUPROPION HYDROCHLORIDE
Active strength 75 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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075491-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 A075491-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2000-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2000-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2000-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2000-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075491-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2000-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075491-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2000-04-17 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPROPION HYDROCHLORIDE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZG7E5POY8O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0615-8581-39 BUPROPION HYDROCHLORIDE 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE A-S Medication Solutions d86e26e0-6e10-4d59-8cc8-94b551774b86 2026-03-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075491 application number: ANDA075491 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE Coupler LLC 47b96919-a8ea-b769-e063-6394a90aa34e 2026-01-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075491 application number: ANDA075491 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE Aurobindo Pharma Limited 6563b923-269f-40c3-b992-cbacdfca6e16 2025-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075491 application number: ANDA075491 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE Bryant Ranch Prepack 9a3b97be-afa3-49e6-962f-662b6807e607 2025-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075491 application number: ANDA075491
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8581-39 00615858139 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8581-39) 2025-07-18 No No Current