Home NDC 42571-242 BUPROPION HYDROCHLORIDE
Product NDC 42571-242
11-digit product format 425710242
Labeler code 42571
Product ID 42571-242_42fa8097-2060-e261-e063-6294a90a6c29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA207403
Marketing category ANDA
Marketing start 2020-07-01
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 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 A207403-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 A207403-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17
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 2 · 74 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 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207403-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2020-04-17 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207403-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2020-04-17 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993687 Internal RxNorm lookup 993691 Internal RxNorm 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 42571-242-01 BUPROPION HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-242 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 11 Current NDC, Legacy NDC, 1 package rows 20240528_03450d2d-97ce-4518-af15-ab85b0d65d76.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42571-242-01 42571024201 100 TABLET, FILM COATED in 1 BOTTLE (42571-242-01) 2020-07-01 0000-00-00 No No Current