Home NDC 42806-413 Bupropion Hydrochloride
Product NDC 42806-413
11-digit product format 428060413
Labeler code 42806
Product ID 42806-413_4bde68a6-0945-b21f-e063-6394a90a3bc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupropion hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA216766
Marketing category ANDA
Marketing start 2023-02-28
Substance BUPROPION HYDROCHLORIDE
Active strength 150 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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216766-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216766-001 AB2
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.
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 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Bupropion Hydrochloride
Brand name suffix SR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPROPION HYDROCHLORIDE 150 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 1801289 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 42806-413-60 Bupropion HydrochlorideSR 60 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-413 BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [EPIC PHARMA, LLC] 4 Current NDC, 1 package rows 20240620_f56ccdb1-f9d9-3e5f-e053-2995a90a8f16.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42806-413-60 42806041360 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-413-60) 2023-02-28 No No Current