Home NDC 68071-3509 PHENDIMETRAZINE TARTRATE
Product NDC 68071-3509
11-digit product format 680713509
Labeler code 68071
Product ID 68071-3509_23225e11-eb3a-d737-e063-6394a90ab811
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phendimetrazine Tartrate
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA040762
Marketing category ANDA
Marketing start 2012-11-20
Substance PHENDIMETRAZINE TARTRATE
Active strength 35 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 A040762-001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040762-001 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 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 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 PHENDIMETRAZINE TARTRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENDIMETRAZINE TARTRATE 35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6985IP0T80 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979549 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 68071-3509-1 PHENDIMETRAZINE TARTRATE 120 in 1 BOTTLE TABLET 120 4 68071-3509-6 PHENDIMETRAZINE TARTRATE 60 in 1 BOTTLE TABLET 60 4 68071-3509-8 PHENDIMETRAZINE TARTRATE 180 in 1 BOTTLE TABLET 180 4 68071-3509-9 PHENDIMETRAZINE TARTRATE 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3509 PHENDIMETRAZINE TARTRATE TABLET [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, 4 package rows 20240929_05bb0569-4eed-2139-e063-6394a90acb6c.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3509-1 68071350901 120 TABLET in 1 BOTTLE (68071-3509-1) 120 tablet 2024-09-27 No No Current 68071-3509-6 68071350906 60 TABLET in 1 BOTTLE (68071-3509-6) 60 tablet 2023-09-19 No No Current 68071-3509-8 68071350908 180 TABLET in 1 BOTTLE (68071-3509-8) 180 tablet 2024-09-27 No No Current 68071-3509-9 68071350909 90 TABLET in 1 BOTTLE (68071-3509-9) 90 tablet 2023-09-19 No No Current