Home NDC 68071-2256 Bupropion Hydrochloride
Product NDC 68071-2256
11-digit product format 680712256
Labeler code 68071
Product ID 68071-2256_1d7692c3-44e2-f52d-e063-6394a90aa73f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA076143
Marketing category ANDA
Marketing start 2006-01-17
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 2026-12-31
Current FDA listing Yes 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 A076143-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 A076143-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17
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 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 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076143-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2006-01-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076143-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB RS 2006-01-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 75 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 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 68071-2256-1 Bupropion Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2256 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240719_aef84c3a-68e2-e9d9-e053-2995a90a4ab8.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 2 of 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Proficient Rx LP 13560bf8-eb25-44f0-968e-db70d51219af 2024-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076143 application number: ANDA076143 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE A-S Medication Solutions 78ef709a-f835-4b03-92dd-16a4c82af0c1 2024-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076143 application number: ANDA076143 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 8d80f882-1887-4d73-b09f-e98fd7ef2acb 2024-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076143 application number: ANDA076143 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC b0e10a21-0ae3-4a8b-bd3e-7a48b30f8418 2023-05-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076143 application number: ANDA076143 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 7d81ed30-ddf7-431a-84f8-6c630cf2b977 2018-10-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076143 application number: ANDA076143
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 68071-2256-1 68071225601 100 TABLET, FILM COATED in 1 BOTTLE (68071-2256-1) 2020-09-10 0000-00-00 No No Current