Home NDC 59651-511 BUPROPION HYDROCHLORIDE
Product NDC 59651-511
11-digit product format 596510511
Labeler code 59651
Product ID 59651-511_cc344f7c-0eb3-4e63-a09e-b682acca2bb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPROPION HYDROCHLORIDE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216051
Marketing category ANDA
Marketing start 2026-07-21
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 43 .
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 A216051-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21 A216051-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21
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.
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 A216051-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216051-002 BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216051-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216051-002 BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB3 2026-07-21 caaa826d4ba7…
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
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993541 Internal RxNorm lookup 993557 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-511-05 59651051105 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-511-05) 2026-07-21 No No Current 59651-511-30 59651051130 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-511-30) 2026-07-21 No No Current 59651-511-90 59651051190 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-511-90) 2026-07-21 No No Current