Home NDC 71335-0451 BENZPHETAMINE HYDROCHLORIDE
Product NDC 71335-0451
11-digit product format 713350451
Labeler code 71335
Product ID 71335-0451_98aa03d7-8df0-4b01-8371-9761a0176afa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzphetamine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090968
Marketing category ANDA
Marketing start 2010-07-21
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 43 .
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 A090968-001 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090968-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 71335-0451-1 BENZPHETAMINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET 30 10 71335-0451-2 BENZPHETAMINE HYDROCHLORIDE 7 in 1 BOTTLE TABLET 7 10 71335-0451-3 BENZPHETAMINE HYDROCHLORIDE 14 in 1 BOTTLE TABLET 14 10 71335-0451-4 BENZPHETAMINE HYDROCHLORIDE 21 in 1 BOTTLE TABLET 21 10 71335-0451-5 BENZPHETAMINE HYDROCHLORIDE 42 in 1 BOTTLE TABLET 42 10 71335-0451-6 BENZPHETAMINE HYDROCHLORIDE 84 in 1 BOTTLE TABLET 84 10 71335-0451-7 BENZPHETAMINE HYDROCHLORIDE 60 in 1 BOTTLE TABLET 60 10 71335-0451-8 BENZPHETAMINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 10 71335-0451-9 BENZPHETAMINE HYDROCHLORIDE 120 in 1 BOTTLE TABLET 120 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0451 BENZPHETAMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 10 Current NDC, Legacy NDC, 9 package rows 20240601_1c726aa7-3b78-45de-aca0-fd8a5fff9403.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0451-1 71335045101 30 TABLET in 1 BOTTLE (71335-0451-1) 30 tablet 2018-08-17 0000-00-00 No No Current 71335-0451-2 71335045102 7 TABLET in 1 BOTTLE (71335-0451-2) 7 tablet 2018-07-25 0000-00-00 No No Current 71335-0451-3 71335045103 14 TABLET in 1 BOTTLE (71335-0451-3) 14 tablet 2018-07-25 0000-00-00 No No Current 71335-0451-4 71335045104 21 TABLET in 1 BOTTLE (71335-0451-4) 21 tablet 2018-09-14 0000-00-00 No No Current 71335-0451-5 71335045105 42 TABLET in 1 BOTTLE (71335-0451-5) 42 tablet 2018-04-23 0000-00-00 No No Current 71335-0451-6 71335045106 84 TABLET in 1 BOTTLE (71335-0451-6) 84 tablet 2024-05-29 0000-00-00 No No Current 71335-0451-7 71335045107 60 TABLET in 1 BOTTLE (71335-0451-7) 60 tablet 2018-07-10 0000-00-00 No No Current 71335-0451-8 71335045108 90 TABLET in 1 BOTTLE (71335-0451-8) 90 tablet 2018-02-12 0000-00-00 No No Current 71335-0451-9 71335045109 120 TABLET in 1 BOTTLE (71335-0451-9) 120 tablet 2018-05-29 0000-00-00 No No Current