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 42 .
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 2026-08-18 06:07:40 2026-07 A216766-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB2 2023-01-09 caaa826d4ba7…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# 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
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 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