Home NDC 42806-443-60 Bupropion Hydrochloride
Product NDC 42806-443
Requested package NDC 42806-443-60
11-digit product format 428060443
Labeler code 42806
Product ID 42806-443_5f06de73-75e0-a51d-e063-6294a90a236d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupropion hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA220529
Marketing category ANDA
Marketing start 2026-09-30
Substance BUPROPION HYDROCHLORIDE
Active strength 200 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 45 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220529-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 A220529-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 A220529-003 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 2026-11-14 07:37:17 2026-10 A220529-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A220529-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A220529-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A220529-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220529-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220529-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220529-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220529-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220529-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220529-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220529-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220529-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220529-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220529-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220529-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-05-04 a50c72e98297…
Observed Orange Book normalized TE history# 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
Brand name suffix SR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPROPION HYDROCHLORIDE 200 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993503 Internal RxNorm lookup 993518 Internal RxNorm lookup 993536 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42806-443-60 42806044360 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-443-60) 2026-09-30 No No Current