PHENDIMETRAZINE TARTRATE

Product NDC: 63629-8536
Requested package NDC: 63629-8536-9
11-digit product format: 636298536
Labeler code: 63629
Product ID: 63629-8536_fee4312c-0952-46f7-83b9-928d29f9be62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENDIMETRAZINE TARTRATE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA085588
Marketing category: ANDA
Marketing start: 2018-07-01
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: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8536	63629-8536-9	D	Discontinued by firm		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 1 · 12 matching rows.

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

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8536-9	63629853609	42 TABLET in 1 BOTTLE (63629-8536-9)	42 tablet	2021-10-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phendimetrazine Tartrate Tablets USP, 35 mg CIII Rx only	Bryant Ranch Prepack	2021-10-21	HUMAN PRESCRIPTION DRUG LABEL	100