Home NDC 45963-142 Bupropion Hydrochloride
Product NDC 45963-142
11-digit product format 459630142
Labeler code 45963
Product ID 45963-142_50d33e34-1a33-4595-b06a-4da2f7d7d518
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA077285
Marketing category ANDA
Marketing start 2015-02-17
Substance BUPROPION HYDROCHLORIDE
Active strength 300 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077285-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB3 2008-11-26 A077285-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB3 2008-08-15
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 2026-08-01 22:54:32 2026-06 A077285-001 BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE / ORAL AB3 2008-11-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A077285-002 BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB3 2008-08-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A077285-001 AB3 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A077285-002 AB3 1 a50c72e98297…
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Actavis Pharma, Inc. df923448-4f81-47af-8e55-f7359746b05f 2026-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077285 application number: ANDA077285 ndc (product): 45963-142 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE HAWAII REPACK, INC. b4a1d3b8-afcf-47e3-96d3-469d8f408a31 2025-06-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077285 application number: ANDA077285 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Asclemed USA, Inc. 637e89e5-8f6e-4392-8045-a778cb9ed138 2025-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077285 application number: ANDA077285 Bupropion Hydrochloride BUPROPION HYDROCHLORIDE Proficient Rx LP 9e2d9c1e-a1de-491d-8f64-34ae60419611 2022-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077285 application number: ANDA077285
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 300 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 993557 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 45963-142-05 Bupropion Hydrochloride 500 in 1 BOTTLE TABLET, EXTENDED RELEASE 500 35 45963-142-30 Bupropion Hydrochloride 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 35 45963-142-90 Bupropion Hydrochloride 90 in 1 BOTTLE TABLET, EXTENDED RELEASE 90 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPROPION HYDROCHLORIDE ACTIVE INGREDIENT ZG7E5POY8O BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 BUPROPION ACTIVE MOIETY 01ZG3TPX31 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 METHACRYLIC ACID INACTIVE INGREDIENT 1CS02G8656 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 7 BUPROPION HYDROCHLORIDE ACTIVE INGREDIENT ZG7E5POY8O BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 BUPROPION ACTIVE MOIETY 01ZG3TPX31 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 METHACRYLIC ACID INACTIVE INGREDIENT 1CS02G8656 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-142 BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] 33 Current NDC, Legacy NDC, 3 package rows 20240625_df923448-4f81-47af-8e55-f7359746b05f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45963-142-05 45963014205 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05) 2015-05-19 0000-00-00 No No Current 45963-142-30 45963014230 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30) 2015-02-17 0000-00-00 No No Current 45963-142-90 45963014290 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90) 2015-06-15 0000-00-00 No No Current