Phendimetrazine Tartrate

Product NDC: 12634-910
11-digit product format: 126340910
Labeler code: 12634
Product ID: 12634-910_366ecdba-3d58-63e5-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phendimetrazine Tartrate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Apotheca Inc.
Application: NDA018074
Marketing category: NDA
Marketing start: 1977-09-06
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: 2019-12-31
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 · 38 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-910		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-09	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-40	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-42	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-45	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-50	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-52	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-58	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-63	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-67	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-69	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-74	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-82	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-90	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-92	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-93	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-94	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-95	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-96	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-97	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-98	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-910	12634-910-99	I	Inactivated by FDA	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 14 · 798 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	12634-910-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-910-96	`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	12634-910-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-910-81	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

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
12634-910-00	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-01	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-09	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-40	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-42	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-45	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-50	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-52	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-54	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-57	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-58	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-59	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-60	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-61	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-63	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-66	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-67	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-69	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-71	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-74	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-78	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-79	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-80	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-81	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-82	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-84	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-85	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-90	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-91	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-92	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-93	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-94	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-95	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-96	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-97	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-98	Phendimetrazine Tartrate Extended-release Capsules CIII
12634-910-99	Phendimetrazine Tartrate Extended-release Capsules CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-910-00	Phendimetrazine Tartrate	10 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	10	5
12634-910-01	Phendimetrazine Tartrate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	5
12634-910-09	Phendimetrazine Tartrate	35 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	35	5
12634-910-40	Phendimetrazine Tartrate	40 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	40	5
12634-910-42	Phendimetrazine Tartrate	42 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	42	5
12634-910-45	Phendimetrazine Tartrate	45 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	45	5
12634-910-50	Phendimetrazine Tartrate	50 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	50	5
12634-910-52	Phendimetrazine Tartrate	12 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	12	5
12634-910-54	Phendimetrazine Tartrate	14 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	14	5
12634-910-57	Phendimetrazine Tartrate	20 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	20	5
12634-910-58	Phendimetrazine Tartrate	28 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	28	5
12634-910-59	Phendimetrazine Tartrate	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30	5
12634-910-60	Phendimetrazine Tartrate	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	5
12634-910-61	Phendimetrazine Tartrate	10 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	10	5
12634-910-63	Phendimetrazine Tartrate	3 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	3	5
12634-910-66	Phendimetrazine Tartrate	6 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	6	5
12634-910-67	Phendimetrazine Tartrate	7 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	7	5
12634-910-69	Phendimetrazine Tartrate	9 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	9	5
12634-910-71	Phendimetrazine Tartrate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	5
12634-910-74	Phendimetrazine Tartrate	24 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	24	5
12634-910-78	Phendimetrazine Tartrate	28 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	28	5
12634-910-79	Phendimetrazine Tartrate	25 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	25	5
12634-910-80	Phendimetrazine Tartrate	20 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	20	5
12634-910-81	Phendimetrazine Tartrate	21 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	21	5
12634-910-82	Phendimetrazine Tartrate	12 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	12	5
12634-910-84	Phendimetrazine Tartrate	14 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	14	5
12634-910-85	Phendimetrazine Tartrate	15 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	15	5
12634-910-90	Phendimetrazine Tartrate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	5
12634-910-91	Phendimetrazine Tartrate	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1	5
12634-910-92	Phendimetrazine Tartrate	2 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	2	5
12634-910-93	Phendimetrazine Tartrate	3 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	3	5
12634-910-94	Phendimetrazine Tartrate	4 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	4	5
12634-910-95	Phendimetrazine Tartrate	5 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	5	5
12634-910-96	Phendimetrazine Tartrate	6 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	6	5
12634-910-97	Phendimetrazine Tartrate	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	5
12634-910-98	Phendimetrazine Tartrate	8 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	8	5
12634-910-99	Phendimetrazine Tartrate	9 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	9	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENDIMETRAZINE TARTRATE	ACTIVE INGREDIENT	6985IP0T80	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
PHENDIMETRAZINE	ACTIVE MOIETY	AB2794W8KV	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PHENDIMETRAZINE TARTRATE CAPSULE [APOTHECA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-910	PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [APOTHECA INC.]	5	Legacy NDC, 37 package rows	20160702_5803a3c0-7434-40f3-af5e-cf33b3e2c448.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

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	5803a3c0-7434-40f3-af5e-cf33b3e2c448	5
979543	24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule	SCD	5803a3c0-7434-40f3-af5e-cf33b3e2c448	5
979543	phendimetrazine 105 MG 24 HR Extended Release Oral Capsule	SY	5803a3c0-7434-40f3-af5e-cf33b3e2c448	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-910-00	12634091000	10 in 1 BOTTLE	Historical
12634-910-01	12634091001	100 in 1 BOTTLE	Historical
12634-910-09	12634091009	35 in 1 BOTTLE	Historical
12634-910-40	12634091040	40 in 1 BOTTLE	Historical
12634-910-42	12634091042	42 in 1 BOTTLE	Historical
12634-910-45	12634091045	45 in 1 BOTTLE	Historical
12634-910-50	12634091050	50 in 1 BOTTLE	Historical
12634-910-52	12634091052	12 in 1 BLISTER PACK	Historical
12634-910-54	12634091054	14 in 1 BLISTER PACK	Historical
12634-910-57	12634091057	20 in 1 BLISTER PACK	Historical
12634-910-58	12634091058	28 in 1 BLISTER PACK	Historical
12634-910-59	12634091059	30 in 1 BLISTER PACK	Historical
12634-910-60	12634091060	60 in 1 BOTTLE	Historical
12634-910-61	12634091061	10 in 1 BLISTER PACK	Historical
12634-910-63	12634091063	3 in 1 BLISTER PACK	Historical
12634-910-66	12634091066	6 in 1 BLISTER PACK	Historical
12634-910-67	12634091067	7 in 1 BLISTER PACK	Historical
12634-910-69	12634091069	9 in 1 BLISTER PACK	Historical
12634-910-71	12634091071	30 in 1 BOTTLE	Historical
12634-910-74	12634091074	24 in 1 BOTTLE	Historical
12634-910-78	12634091078	28 in 1 BOTTLE	Historical
12634-910-79	12634091079	25 in 1 BOTTLE	Historical
12634-910-80	12634091080	20 in 1 BOTTLE	Historical
12634-910-81	12634091081	21 in 1 BOTTLE	Historical
12634-910-82	12634091082	12 in 1 BOTTLE	Historical
12634-910-84	12634091084	14 in 1 BOTTLE	Historical
12634-910-85	12634091085	15 in 1 BOTTLE	Historical
12634-910-90	12634091090	90 in 1 BOTTLE	Historical
12634-910-91	12634091091	1 in 1 BLISTER PACK	Historical
12634-910-92	12634091092	2 in 1 BOTTLE	Historical
12634-910-93	12634091093	3 in 1 BOTTLE	Historical
12634-910-94	12634091094	4 in 1 BOTTLE	Historical
12634-910-95	12634091095	5 in 1 BOTTLE	Historical
12634-910-96	12634091096	6 in 1 BOTTLE	Historical
12634-910-97	12634091097	7 in 1 BOTTLE	Historical
12634-910-98	12634091098	8 in 1 BOTTLE	Historical
12634-910-99	12634091099	9 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phendimetrazine Tartrate Extended-release Capsules CIII	Apotheca Inc.	2016-06-29	HUMAN PRESCRIPTION DRUG LABEL	5