Home NDC 46708-127 Bupropion Hydrochloride
Product NDC 46708-127
11-digit product format 467080127
Labeler code 46708
Product ID 46708-127_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 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 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 A203013-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2018-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203013-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2018-06-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-127-31 Bupropion Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 4 46708-127-71 Bupropion Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-127 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20240111_ef0bb8f2-7710-4236-8b47-57b74c8bca3e.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 · 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): 46708-127
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 46708-127-31 46708012731 100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31) 2018-06-18 0000-00-00 No No Current 46708-127-71 46708012771 500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71) 2018-06-18 0000-00-00 No No Current