Home NDC 46708-118 Bupropion Hydrochloride
Product NDC 46708-118
11-digit product format 467080118
Labeler code 46708
Product ID 46708-118_b09bdaa7-0871-4741-b5cd-dd30d683613c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA203013
Marketing category ANDA
Marketing start 2018-06-18
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 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 A203013-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 A203013-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08
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 · 82 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 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupropion Hydrochloride BUPROPION HYDROCHLORIDE REMEDYREPACK INC. 990587bd-4c7d-4a36-8a38-3104648ab3a2 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203013 application number: ANDA203013 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE REMEDYREPACK INC. 81d251aa-a8e8-493e-94ed-12f6fb8902e6 2025-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203013 application number: ANDA203013 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Alembic Pharmaceuticals Inc. b303a0ad-5971-44ab-937c-bcf3ff650358 2025-09-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203013 application number: ANDA203013 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Alembic Pharmaceuticals Limited ef0bb8f2-7710-4236-8b47-57b74c8bca3e 2024-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203013 application number: ANDA203013 ndc (product): 46708-118
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 · 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-118-31 Bupropion Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 4 46708-118-91 Bupropion Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-118 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20240111_ef0bb8f2-7710-4236-8b47-57b74c8bca3e.zip
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 46708-118-31 46708011831 100 TABLET, FILM COATED in 1 BOTTLE (46708-118-31) 2018-06-18 0000-00-00 No No Current 46708-118-71 46708011871 500 TABLET, FILM COATED in 1 BOTTLE (46708-118-71) 2018-06-18 0000-00-00 No No Current 46708-118-91 46708011891 1000 TABLET, FILM COATED in 1 BOTTLE (46708-118-91) 2018-06-18 No No Current