Home NDC 53808-0213 Bupropion Hydrochloride
Product NDC 53808-0213
11-digit product format 538080213
Labeler code 53808
Product ID 53808-0213_bd3c717d-992b-420d-afd5-fa67e62964f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA075310
Marketing category ANDA
Marketing start 2009-07-01
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 E
Listing certified through 2017-12-31
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 · 44 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 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 53808-0213-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0213-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0213-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0213-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0213-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0213-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0213-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0213-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0213-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0213-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0213-1 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075310-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 A075310-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29
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 · 86 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 2026-09-14 22:38:34 2026-08 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075310-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 1999-11-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075310-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 1999-11-29 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-0213-1 Bupropion Hydrochloride 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 BUPROPION ACTIVE MOIETY 01ZG3TPX31 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 GLUTAMIC ACID HYDROCHLORIDE INACTIVE INGREDIENT M0C2SP444T BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MALEIC ACID INACTIVE INGREDIENT 91XW058U2C BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0213 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20100331_a6f7f0e4-87ea-4508-b899-91c8ba819ab7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0213-1 53808021301 30 in 1 BLISTER PACK Historical