Home NDC 67544-892 Bupropion Hydrochloride
Product NDC 67544-892
11-digit product format 675440892
Labeler code 67544
Product ID 67544-892_4656613f-ab12-4d5f-a7ad-573b6f0e2e3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupropion Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075584
Marketing category ANDA
Marketing start 2000-02-07
Marketing end 0000-00-00
Substance BUPROPION HYDROCHLORIDE
Active strength 75 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 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 3 · 126 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075584-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 A075584-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07
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.
Product history page 1 of 3 · 84 observed 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 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67544-892-51 Bupropion Hydrochloride 6000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 6000 3 67544-892-53 Bupropion Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 3 67544-892-70 Bupropion Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 3 67544-892-80 Bupropion Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 3 67544-892-94 Bupropion Hydrochloride 360 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 360 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPROPION HYDROCHLORIDE ACTIVE INGREDIENT ZG7E5POY8O BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 BUPROPION ACTIVE MOIETY 01ZG3TPX31 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-892 BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC, 5 package rows 20140521_c46845ee-ed1c-4788-882c-b9a84ff88bab.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 Status 67544-892-51 67544089251 6000 in 1 BOTTLE, PLASTIC Historical 67544-892-53 67544089253 60 in 1 BOTTLE, PLASTIC Historical 67544-892-70 67544089270 120 in 1 BOTTLE, PLASTIC Historical 67544-892-80 67544089280 180 in 1 BOTTLE, PLASTIC Historical 67544-892-94 67544089294 360 in 1 BOTTLE, PLASTIC Historical