Home NDC 49999-349 Bupropion Hydrochloride
Product NDC 49999-349
11-digit product format 499990349
Labeler code 49999
Product ID 49999-349_bd669c40-51ba-446a-baa0-0fa40978b4e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA075584
Marketing category ANDA
Marketing start 2000-02-07
Marketing end 0000-00-00
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 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 2 · 76 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49999-349-90 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49999-349-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49999-349-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49999-349-90 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49999-349-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49999-349-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49999-349-90 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49999-349-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49999-349-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49999-349-90 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49999-349-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49999-349-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49999-349-90 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49999-349-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49999-349-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49999-349-90 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49999-349-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49999-349-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49999-349-90 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49999-349-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49999-349-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49999-349-90 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49999-349-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49999-349-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49999-349-60 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49999-349-90 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49999-349-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49999-349-60 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49999-349-90 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49999-349-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49999-349-60 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49999-349-90 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49999-349-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49999-349-60 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49999-349-90 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49999-349-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49999-349-60 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49999-349-90 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49999-349-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49999-349-60 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49999-349-90 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49999-349-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49999-349-60 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49999-349-90 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49999-349-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# 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.