Home NDC 0615-5554 Bupropion Hydrochloride
Product NDC 0615-5554
11-digit product format 006155554
Labeler code 0615
Product ID 0615-5554_4658a59c-aa91-472c-9932-6c46caa4f75e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA075584
Marketing category ANDA
Marketing start 2000-02-07
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-5554-39 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-5554-39 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-5554-39 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-5554-39 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-5554-39 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-5554-39 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-5554-39 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-5554-39 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-5554-39 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-5554-39 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-5554-39 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-5554-39 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075584-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 A075584-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPROPION HYDROCHLORIDE ACTIVE INGREDIENT ZG7E5POY8O BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 BUPROPION ACTIVE MOIETY 01ZG3TPX31 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 HYPROMELLOSE 2910 (15 CPS) INACTIVE INGREDIENT 36SFW2JZ0W BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4
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 · 1 matching rows.