PHENDIMETRAZINE TARTRATE

Product NDC: 72989-409
11-digit product format: 729890409
Labeler code: 72989
Product ID: 72989-409_72552285-ab14-4e9f-957a-d913b31bdd84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENDIMETRAZINE TARTRATE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Acertis Pharmaceuticals, LLC
Application: NDA018074
Marketing category: NDA
Marketing start: 2022-11-01
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: 2026-12-31
Current FDA listing: Yes

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	72989-409	72989-409-11	D	Discontinued by firm		2026-08-17

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 · 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 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
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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018074-001	PHENDIMETRAZINE TARTRATE	105MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS, Approved before 1982	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: PHENDIMETRAZINE TARTRATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENDIMETRAZINE TARTRATE	105 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6985IP0T80	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979543	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
162140d3-b833-4633-9759-95821a46a690	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
71525015-bcb9-5864-7749-4b5f528a6b6a	Product name	2	20180419
977c925f-5460-67b1-e843-25a0ba370df1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72989-409-11	PHENDIMETRAZINE TARTRATE	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000		3
72989-409-30	PHENDIMETRAZINE TARTRATE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72989-409-30	EA - Each	72989-409	a2247a7f-80b7-476d-9823-f709ccd84c8b	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72989-409	PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [ACERTIS PHARMACEUTICALS, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230826_162140d3-b833-4633-9759-95821a46a690.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 · 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 ndc (product): 72989-409

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	162140d3-b833-4633-9759-95821a46a690	3
979543	24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule	SCD	162140d3-b833-4633-9759-95821a46a690	3
979543	phendimetrazine 105 MG 24 HR Extended Release Oral Capsule	SY	162140d3-b833-4633-9759-95821a46a690	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72989-409-11	72989040911	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-11)	2022-11-01	0000-00-00	No	No	Current
72989-409-30	72989040930	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-30)	2022-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phendimetrazine Tartrate Extended-Release Capsules CIII	Acertis Pharmaceuticals, LLC	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	3