Home NDC 43063-541 BENZPHETAMINE HYDROCHLORIDE
Product NDC 43063-541
11-digit product format 430630541
Labeler code 43063
Product ID 43063-541_41393fbe-29e5-dd10-e063-6394a90a5a13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzphetamine hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A090968-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL AA RS 2010-07-20 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 43063-541-14 BENZPHETAMINE HYDROCHLORIDE 14 in 1 BOTTLE, PLASTIC TABLET 14 25 43063-541-30 BENZPHETAMINE HYDROCHLORIDE 30 in 1 BOTTLE, PLASTIC TABLET 30 25 43063-541-45 BENZPHETAMINE HYDROCHLORIDE 45 in 1 BOTTLE, PLASTIC TABLET 45 25 43063-541-60 BENZPHETAMINE HYDROCHLORIDE 60 in 1 BOTTLE, PLASTIC TABLET 60 25 43063-541-90 BENZPHETAMINE HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET 90 25 43063-541-98 BENZPHETAMINE HYDROCHLORIDE 120 in 1 BOTTLE, PLASTIC TABLET 120 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZPHETAMINE HYDROCHLORIDE ACTIVE INGREDIENT 43DWT87QT7 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 BENZPHETAMINE ACTIVE MOIETY 0M3S43XK27 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BENZPHETAMINE HYDROCHLORIDE (BENZPHETAMINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-541 BENZPHETAMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 24 Current NDC, Legacy NDC, 6 package rows 20240809_2b7014af-0cc9-4199-90f2-ec07ac02f8cf.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 43063-541-14 43063054114 14 TABLET in 1 BOTTLE, PLASTIC (43063-541-14) 14 tablet 2014-10-22 0000-00-00 No No Current 43063-541-30 43063054130 30 TABLET in 1 BOTTLE, PLASTIC (43063-541-30) 30 tablet 2014-10-22 0000-00-00 No No Current 43063-541-45 43063054145 45 TABLET in 1 BOTTLE, PLASTIC (43063-541-45) 45 tablet 2014-10-22 0000-00-00 No No Current 43063-541-60 43063054160 60 TABLET in 1 BOTTLE, PLASTIC (43063-541-60) 60 tablet 2014-10-22 0000-00-00 No No Current 43063-541-90 43063054190 90 TABLET in 1 BOTTLE, PLASTIC (43063-541-90) 90 tablet 2014-10-22 0000-00-00 No No Current 43063-541-98 43063054198 120 TABLET in 1 BOTTLE, PLASTIC (43063-541-98) 120 tablet 2010-07-21 0000-00-00 No No Current