Home NDC 46672-844 benzphetamine hydrochloride
Product NDC 46672-844
11-digit product format 466720844
Labeler code 46672
Product ID 46672-844_a4083a27-aa97-6830-e053-2a95a90aeda2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzphetamine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mikart, LLC
Application ANDA090473
Marketing category ANDA
Marketing start 2011-11-01
Marketing end 0000-00-00
Substance BENZPHETAMINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A090473-001 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 A090473-002 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090473-002 AA
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 · 88 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 2026-10-15 13:18:30 2026-09 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090473-001 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2010-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090473-002 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2010-09-15 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A090473-002 AA 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090473-002 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090473-002 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090473-002 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46672-844-10 46672084410 100 TABLET in 1 BOTTLE, PLASTIC (46672-844-10) 100 tablet 2011-11-01 0000-00-00 No No Current 46672-844-50 46672084450 500 TABLET in 1 BOTTLE, PLASTIC (46672-844-50) 500 tablet 2011-11-01 0000-00-00 No No Current