Phendimetrazine Tartrate

Product NDC: 21695-597
11-digit product format: 216950597
Labeler code: 21695
Product ID: 21695-597_f31c768e-4156-4ebe-8dce-763bf940ab1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phendimetrazine Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA085588
Marketing category: ANDA
Marketing start: 2009-06-01
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: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-597		I	Inactivated by FDA	2026-08-11
excluded package	package	21695-597	21695-597-07	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-597	21695-597-21	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-597	21695-597-42	I	Inactivated by FDA	2026-08-11
excluded package	package	21695-597	21695-597-60	I	Inactivated by FDA	2026-08-11

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-597-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-597-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-597-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-597-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-597-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-597-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-597-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-597-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-597-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-597-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-597-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-597-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-597-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-597-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-597-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-597-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-597-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-597-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-597-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-597-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-597-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-597-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-597-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-597-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-597-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-597-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-597-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-597-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-597-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-597-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-597-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-597-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-597-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-597-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-597-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-597-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-597-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-597-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-597-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-597-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-597-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-597-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-597-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-597-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-597-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-597-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-597-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-597-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085588-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085588-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085588-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085588-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085588-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085588-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085588-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085588-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085588-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085588-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085588-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085588-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085588-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085588-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085588-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085588-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085588-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085588-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085588-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085588-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085588-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085588-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085588-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085588-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085588-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085588-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085588-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085588-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085588-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085588-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085588-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085588-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085588-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085588-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085588-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085588-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085588-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085588-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085588-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085588-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
71525015-bcb9-5864-7749-4b5f528a6b6a	Product name	2	20180419
977c925f-5460-67b1-e843-25a0ba370df1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
21695-597-07	Phendimetrazine Tartrate 35mg Tablet
21695-597-21	Phendimetrazine Tartrate 35mg Tablet
21695-597-42	Phendimetrazine Tartrate 35mg Tablet
21695-597-60	Phendimetrazine Tartrate 35mg Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-597-07	Phendimetrazine Tartrate	7 in 1 BOTTLE	TABLET	7	1
21695-597-21	Phendimetrazine Tartrate	21 in 1 BOTTLE	TABLET	21	1
21695-597-42	Phendimetrazine Tartrate	42 in 1 BOTTLE	TABLET	42	1
21695-597-60	Phendimetrazine Tartrate	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-597-07	EA - Each	21695-597	1dc5d3f4-c694-4cd5-b9b5-eb121930530e	1	2012-07-24
21695-597-21	EA - Each	21695-597	c114c4f5-8d6c-4a57-936e-e9128e6005a6	1	2012-07-24
21695-597-42	EA - Each	21695-597	c07efac2-3c54-4f61-a2c7-3c6ee5e02fe5	1	2012-07-24
21695-597-60	EA - Each	21695-597	cf03ec17-41c5-4a54-b5bd-55c2c4c09a7a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENDIMETRAZINE TARTRATE	ACTIVE INGREDIENT	6985IP0T80	PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]	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. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-597	PHENDIMETRAZINE TARTRATE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20110113_f31c768e-4156-4ebe-8dce-763bf940ab1b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	75f6c4bc-ed72-498a-822c-ecc2a13df958	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Virtus Pharmaceuticals, LLC	cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	137e5fcd-9536-4fb9-9885-5dfd1127c35a	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085588 application number: ANDA085588

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6985IP0T80	PHENDIMETRAZINE TARTRATE	50-58-8	PHENDIMETRAZINE TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979549	phendimetrazine tartrate 35 MG Oral Tablet	PSN	f31c768e-4156-4ebe-8dce-763bf940ab1b	1
979549	phendimetrazine tartrate 35 MG Oral Tablet	SCD	f31c768e-4156-4ebe-8dce-763bf940ab1b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-597-07	21695059707	7 in 1 BOTTLE	Historical
21695-597-21	21695059721	21 in 1 BOTTLE	Historical
21695-597-42	21695059742	42 in 1 BOTTLE	Historical
21695-597-60	21695059760	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phendimetrazine Tartrate 35mg Tablet	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1