Home NDC 0185-4057 Phendimetrazine Tartrate
Product NDC 0185-4057
11-digit product format 001854057
Labeler code 0185
Product ID 0185-4057_17fbdc0f-dacb-43ec-a3b2-99c52dd2fe1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phendimetrazine Tartrate
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA085588
Marketing category ANDA
Marketing start 1977-08-19
Marketing end 2024-01-31
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A085588-001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A085588-001 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 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A085588-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA Approved before 1982 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENDIMETRAZINE TARTRATE ACTIVE INGREDIENT 6985IP0T80 PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 PHENDIMETRAZINE ACTIVE MOIETY AB2794W8KV PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENDIMETRAZINE TARTRATE TABLET [EON LABS, INC.] 13 PHENDIMETRAZINE TARTRATE ACTIVE INGREDIENT 6985IP0T80 PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 PHENDIMETRAZINE ACTIVE MOIETY AB2794W8KV PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENDIMETRAZINE TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.] 2 PHENDIMETRAZINE TARTRATE ACTIVE INGREDIENT 6985IP0T80 PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 PHENDIMETRAZINE TARTRATE ACTIVE INGREDIENT 6985IP0T80 PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 PHENDIMETRAZINE ACTIVE MOIETY AB2794W8KV PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 PHENDIMETRAZINE ACTIVE MOIETY AB2794W8KV PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PHENDIMETRAZINE TARTRATE TABLET [STAT RX USA LLC] 1
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 0185-4057-01 00185405701 100 TABLET in 1 BOTTLE (0185-4057-01) 100 tablet 1977-08-19 2024-01-31 No No Current 0185-4057-10 00185405710 1000 TABLET in 1 BOTTLE (0185-4057-10) 1000 tablet 1977-08-19 2023-10-31 No No Current