Phendimetrazine Tartrate

Product NDC: 50090-6552
11-digit product format: 500906552
Labeler code: 50090
Product ID: 50090-6552_a420ce0d-e458-46ca-aa9c-aaba680e455b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phendimetrazine Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA091042
Marketing category: ANDA
Marketing start: 2010-09-15
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: 2026-12-31
Current FDA listing: Yes

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
A091042-001	PHENDIMETRAZINE TARTRATE	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA		2010-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091042-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091042-001	PHENDIMETRAZINE TARTRATE	35MG	TABLET / ORAL	AA	2010-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091042-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091042-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091042-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091042-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091042-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091042-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091042-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091042-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091042-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091042-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091042-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091042-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091042-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091042-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091042-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091042-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091042-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091042-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091042-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091042-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091042-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091042-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091042-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091042-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091042-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091042-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091042-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091042-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091042-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091042-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091042-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091042-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091042-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091042-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091042-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091042-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091042-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091042-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091042-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091042-001	AA	1	`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	35 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
979549	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
7adaf128-fef4-4bbf-8b4a-875fe46bf68a	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6552-2	Phendimetrazine Tartrate	90 in 1 BOTTLE	TABLET	90		1
50090-6552-9	Phendimetrazine Tartrate	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6552-2	EA - Each	50090-6552	911f80f2-5023-4415-a19e-5c62d33e957c	1	2023-08-08
50090-6552-9	EA - Each	50090-6552	eb3d7361-4ae9-4329-bee8-47e7deb12527	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6552	PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS]	1	Current NDC, 2 package rows	20230719_7adaf128-fef4-4bbf-8b4a-875fe46bf68a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Preferred Pharmaceuticals Inc.	767b5386-1e56-4eeb-8d59-510b940ab75e	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Calvin Scott & Co., Inc.	f5c30a88-5814-5b42-e053-2995a90a437a	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	ef4cfd54-7d3e-4571-ae77-38ab2fd1af3d	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals, Inc.	342bc2a2-2751-b51a-e063-6394a90a4c43	2025-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	f1d265e1-522e-4a62-afda-29477fb94b8d	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	PD-Rx Pharmaceuticals, Inc.	467ae7d7-e342-423b-be89-5d38c1abf3c9	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	KVK-TECH, INC	07bf3488-09e7-436f-af3f-94c35a7be025	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	NuCare Pharmaceuticals, Inc,	40e5b0bf-347e-30f6-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	Bryant Ranch Prepack	1c2370fd-6b40-48dc-a42d-2488041d5b37	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042
Phendimetrazine Tartrate	PHENDIMETRAZINE TARTRATE	A-S Medication Solutions	7adaf128-fef4-4bbf-8b4a-875fe46bf68a	2023-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091042 application number: ANDA091042 ndc (product): 50090-6552

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	7adaf128-fef4-4bbf-8b4a-875fe46bf68a	1
979549	phendimetrazine tartrate 35 MG Oral Tablet	SCD	7adaf128-fef4-4bbf-8b4a-875fe46bf68a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6552-2	50090655202	90 TABLET in 1 BOTTLE (50090-6552-2)	90 tablet	2023-07-12	No	No	Current
50090-6552-9	50090655209	30 TABLET in 1 BOTTLE (50090-6552-9)	30 tablet	2023-07-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENDIMETRAZINE TARTRATE TABLETS, USP 35 mg, CIII Rx Only	A-S Medication Solutions	2023-07-18	HUMAN PRESCRIPTION DRUG LABEL	1