Home NDC 71335-0877-5 bupropion Hydrochloride
Product NDC 71335-0877
Requested package NDC 71335-0877-5
11-digit product format 713350877
Labeler code 71335
Product ID 71335-0877_7a02762a-5d8d-4874-9fc2-b4d74458eee7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupropion Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207389
Marketing category ANDA
Marketing start 2018-05-26
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 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-0877 71335-0877-5 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-0877 71335-0877-5 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A207389-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 A207389-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18
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 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL 2017-09-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL 2017-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-09-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-09-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-09-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207389-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2017-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207389-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-18 74a2ff9319b5…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPROPION HYDROCHLORIDE 100 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993687 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0877-1 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-2 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-3 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-4 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-5 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-6 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-7 2024-05-16 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-1 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-2 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-3 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-4 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-5 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-6 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985 71335-0877-7 2024-01-30 These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0877-1 bupropion Hydrochloride 60 in 1 BOTTLE TABLET 60 8 71335-0877-2 bupropion Hydrochloride 30 in 1 BOTTLE TABLET 30 8 71335-0877-3 bupropion Hydrochloride 100 in 1 BOTTLE TABLET 100 8 71335-0877-4 bupropion Hydrochloride 90 in 1 BOTTLE TABLET 90 8 71335-0877-5 bupropion Hydrochloride 120 in 1 BOTTLE TABLET 120 8 71335-0877-6 bupropion Hydrochloride 15 in 1 BOTTLE TABLET 15 8 71335-0877-7 bupropion Hydrochloride 21 in 1 BOTTLE TABLET 21 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0877 BUPROPION HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 8 Current NDC, Legacy NDC, 7 package rows 20240517_c1fa6fce-272b-4497-a958-177f0bafdfc7.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0877-5 71335087705 120 TABLET in 1 BOTTLE (71335-0877-5) 120 tablet 2021-12-27 0000-00-00 No No Current