PHENDIMETRAZINE TARTRATE

Product NDC: 69543-409
Requested package NDC: 69543-409-30
11-digit product format: 695430409
Labeler code: 69543
Product ID: 69543-409_67788713-a4bc-480f-858a-606cd0d0800b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENDIMETRAZINE TARTRATE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Virtus Pharmaceuticals, LLC
Application: NDA018074
Marketing category: NDA
Marketing start: 2018-07-01
Marketing end: 0000-00-00
Substance: PHENDIMETRAZINE TARTRATE
Active strength: 105 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: 2023-12-31
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	69543-409	69543-409-30	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
N018074-001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-409-10	EA - Each	69543-409	e4c06ce5-8675-4024-b928-58e087fdacfd	1	2018-08-13
69543-409-30	EA - Each	69543-409	c78c6a48-8ce7-4962-b4b6-5d5b88c3ba9d	1	2021-06-02

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	Acertis Pharmaceuticals, LLC	162140d3-b833-4633-9759-95821a46a690	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018074 application number: NDA018074

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
979543	phendimetrazine tartrate 105 MG 24HR Extended Release Oral Capsule	PSN	40787112-bb0a-4e85-a3f1-8719e3d21fb0	1
979543	24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule	SCD	40787112-bb0a-4e85-a3f1-8719e3d21fb0	1
979543	phendimetrazine 105 MG 24 HR Extended Release Oral Capsule	SY	40787112-bb0a-4e85-a3f1-8719e3d21fb0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-409-30	69543040930	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-409-30)	2021-05-01	2023-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phendimetrazine Tartrate Extended-Release Capsules CIII	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	7
Phendimetrazine Tartrate Extended-Release Capsules CIII	Virtus Pharmaceuticals, LLC	2022-10-10	HUMAN PRESCRIPTION DRUG LABEL	6
Phendimetrazine Tartrate Extended-Release Capsules CIII	PD-Rx Pharmaceuticals, Inc.	2021-11-09	HUMAN PRESCRIPTION DRUG LABEL	10
Phendimetrazine Tartrate Extended-Release Capsules CIII Rx only	CALVIN, SCOTT AND COMPANY, INCORPORATED	2019-11-15	HUMAN PRESCRIPTION DRUG LABEL	1