Home NDC 64850-440 PHENDIMETRAZINE TARTRATE
Product NDC 64850-440
11-digit product format 648500440
Labeler code 64850
Product ID 64850-440_97b69c02-a69e-46fe-8686-4b4d8ceb5dca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phendimetrazine Tartrate
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, 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 1 .
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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040762-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 2008-01-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 64850-440-01 PHENDIMETRAZINE TARTRATE 100 in 1 BOTTLE TABLET 100 2 64850-440-10 PHENDIMETRAZINE TARTRATE 1000 in 1 BOTTLE TABLET 1000 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENDIMETRAZINE TARTRATE ACTIVE INGREDIENT 6985IP0T80 PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 PHENDIMETRAZINE ACTIVE MOIETY AB2794W8KV PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-440 PHENDIMETRAZINE TARTRATE TABLET [ELITE LABORATORIES, INC] 2 Current NDC, Legacy NDC, 2 package rows 20190208_42ecacde-6859-47c6-ba44-13fb4f3b5448.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 Marketing end Sample Exclude flag Status 64850-440-01 64850044001 100 TABLET in 1 BOTTLE (64850-440-01) 100 tablet 2012-11-20 0000-00-00 No No Current 64850-440-10 64850044010 1000 TABLET in 1 BOTTLE (64850-440-10) 1000 tablet 2012-11-20 0000-00-00 No No Current