FDA.reportPublic FDA data

phendimetrazine tartrate

Product NDC
63629-7319
Requested package NDC
63629-7319-3
11-digit product format
636297319
Labeler code
63629
Product ID
63629-7319_d8809325-6b61-455f-9a58-e9b1ed014911
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phendimetrazine tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA089452
Marketing category
ANDA
Marketing start
2001-07-26
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-731963629-7319-3DDiscontinued by firm2026-08-17

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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089452-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A089452-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089452-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA1991-10-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A089452-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089452-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089452-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089452-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089452-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089452-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089452-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089452-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089452-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089452-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089452-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089452-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089452-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089452-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089452-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089452-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089452-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089452-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089452-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089452-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089452-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089452-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A089452-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089452-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089452-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089452-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089452-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089452-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089452-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089452-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089452-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089452-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089452-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089452-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089452-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089452-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089452-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089452-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089452-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089452-001AA1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7319-02020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-12020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-22020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-32020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-42020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-52020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-62020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-72020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-82020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-92020-10-1602e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-02020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-12020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-22020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-32020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-42020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-52020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-62020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-72020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-82020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed
63629-7319-92020-01-3102e4f4fe-fa05-4162-a375-66c9a92018ed

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7319-363629731903180 TABLET in 1 BOTTLE (63629-7319-3) 180 tablet2017-08-010000-00-00NoNoCurrent