Home NDC 12634-539 phendimetrazine tartrate
Product NDC 12634-539
11-digit product format 126340539
Labeler code 12634
Product ID 12634-539_37b5963b-0bc0-073e-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phendimetrazine tartrate
Dosage form TABLET
Route ORAL
Labeler Apotheca Inc.
Application ANDA089452
Marketing category ANDA
Marketing start 2000-07-05
Marketing end 0000-00-00
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 2020-12-31
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 14 · 818 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-54 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-97 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-85 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-94 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-52 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-95 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-60 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-45 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-80 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-67 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-61 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-63 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-81 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-40 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-50 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-09 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-84 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-98 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-79 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-99 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-74 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-00 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-91 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-78 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-42 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-44 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-81 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-57 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-90 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-59 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-69 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-42 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-82 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-45 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-58 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-91 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-92 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-93 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-78 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-66 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-71 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 12634-539-96 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-54 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-97 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-85 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-94 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-52 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-95 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-45 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-80 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-67 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-61 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 12634-539-63 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…
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 A089452-001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089452-001 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 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089452-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL AA 1991-10-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-539 PHENDIMETRAZINE TARTRATE TABLET [APOTHECA INC.] 1 Legacy NDC, 37 package rows 20160719_37b5963b-0bbe-073e-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 12634-539-00 12634053900 10 in 1 BOTTLE Historical 12634-539-01 12634053901 100 in 1 BOTTLE Historical 12634-539-09 12634053909 35 in 1 BOTTLE Historical 12634-539-40 12634053940 40 in 1 BOTTLE Historical 12634-539-42 12634053942 42 in 1 BOTTLE Historical 12634-539-45 12634053945 45 in 1 BOTTLE Historical 12634-539-50 12634053950 50 in 1 BOTTLE Historical 12634-539-52 12634053952 12 in 1 BLISTER PACK Historical 12634-539-54 12634053954 14 in 1 BLISTER PACK Historical 12634-539-57 12634053957 20 in 1 BLISTER PACK Historical 12634-539-58 12634053958 28 in 1 BLISTER PACK Historical 12634-539-59 12634053959 30 in 1 BLISTER PACK Historical 12634-539-60 12634053960 60 in 1 BOTTLE Historical 12634-539-61 12634053961 10 in 1 BLISTER PACK Historical 12634-539-63 12634053963 3 in 1 BLISTER PACK Historical 12634-539-66 12634053966 6 in 1 BLISTER PACK Historical 12634-539-67 12634053967 7 in 1 BLISTER PACK Historical 12634-539-69 12634053969 9 in 1 BLISTER PACK Historical 12634-539-71 12634053971 30 in 1 BOTTLE Historical 12634-539-74 12634053974 24 in 1 BOTTLE Historical 12634-539-78 12634053978 28 in 1 BOTTLE Historical 12634-539-79 12634053979 25 in 1 BOTTLE Historical 12634-539-80 12634053980 20 in 1 BOTTLE Historical 12634-539-81 12634053981 21 in 1 BOTTLE Historical 12634-539-82 12634053982 12 in 1 BOTTLE Historical 12634-539-84 12634053984 14 in 1 BOTTLE Historical 12634-539-85 12634053985 15 in 1 BOTTLE Historical 12634-539-90 12634053990 90 in 1 BOTTLE Historical 12634-539-91 12634053991 1 in 1 BLISTER PACK Historical 12634-539-92 12634053992 2 in 1 BOTTLE Historical 12634-539-93 12634053993 3 in 1 BOTTLE Historical 12634-539-94 12634053994 4 in 1 BOTTLE Historical 12634-539-95 12634053995 5 in 1 BOTTLE Historical 12634-539-96 12634053996 6 in 1 BOTTLE Historical 12634-539-97 12634053997 7 in 1 BOTTLE Historical 12634-539-98 12634053998 8 in 1 BOTTLE Historical 12634-539-99 12634053999 9 in 1 BOTTLE Historical