Home NDC 33342-526 Bupropion Hydrochloride
Product NDC 33342-526
11-digit product format 333420526
Labeler code 33342
Product ID 33342-526_6127b24e-261c-4b64-8423-ebe583676abe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA218567
Marketing category ANDA
Marketing start 2026-06-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218567-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 A218567-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 A218567-003 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23
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 2026-09-14 22:38:34 2026-08 A218567-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218567-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218567-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218567-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218567-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218567-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218567-001 BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218567-002 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218567-003 BUPROPION HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE / ORAL AB1 2026-06-23 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 100 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 33342-526-09 33342052609 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-526-09) 2026-06-23 No No Current 33342-526-11 33342052611 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-526-11) 2026-06-23 No No Current 33342-526-15 33342052615 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-526-15) 2026-06-23 No No Current