Home NDC 42806-081 Benzphetamine Hydrochloride
Product NDC 42806-081
11-digit product format 428060081
Labeler code 42806
Product ID 42806-081_b4e5d191-8cbf-4111-a07b-025b920269c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzphetamine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA090346
Marketing category ANDA
Marketing start 2015-12-16
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090346-001 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090346-001 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 2 · 42 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 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090346-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2015-12-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Benzphetamine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZPHETAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 43DWT87QT7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904368 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 42806-081-01 Benzphetamine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 8 42806-081-05 Benzphetamine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 8 42806-081-30 Benzphetamine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-081 BENZPHETAMINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20231228_f6d9b369-4b64-4d3f-844d-5d60dd257c55.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 Marketing start Marketing end Sample Exclude flag Status 42806-081-01 42806008101 100 TABLET, FILM COATED in 1 BOTTLE (42806-081-01) 2015-12-16 0000-00-00 No No Current 42806-081-05 42806008105 500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05) 2015-12-16 0000-00-00 No No Current 42806-081-30 42806008130 30 TABLET, FILM COATED in 1 BOTTLE (42806-081-30) 2015-12-16 0000-00-00 No No Current