diethylpropion hydrochloride er

Product NDC: 12634-691
11-digit product format: 126340691
Labeler code: 12634
Product ID: 12634-691_46d9dd37-a8c5-4c01-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diethylpropion hydrochloride er
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: NDA012546
Marketing category: NDA
Marketing start: 1960-11-17
Marketing end: 0000-00-00
Substance: DIETHYLPROPION HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule: CIV
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 · 47 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-691		D	Discontinued by firm	2026-08-17
excluded product	product	12634-691		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-60	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-71	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-78	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-84	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-90	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-91	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-97	D	Discontinued by firm	2026-08-17
excluded package	package	12634-691	12634-691-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-09	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-12	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-18	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-40	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-42	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-45	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-50	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-52	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-54	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-63	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-67	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-69	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-74	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-78	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-81	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-82	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-84	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-90	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-92	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-93	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-94	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-95	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-96	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-97	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-98	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-691	12634-691-99	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 16 · 915 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-69	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-79	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-63	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-78	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-96	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-18	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-57	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-74	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-78	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-81	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-54	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-97	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-42	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-84	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-80	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-85	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-52	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-95	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-66	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-12	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-71	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-71	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-91	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-99	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-94	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-91	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-82	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-98	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-84	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-09	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-97	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-61	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-59	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-67	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-45	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-92	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-691-93	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-69	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-79	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-63	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-78	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-96	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-40	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-18	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-57	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-691-60	I	Inactivated by FDA	`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
N012546-001	TENUATE DOSPAN	DIETHYLPROPION HYDROCHLORIDE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, 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	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012546-001	TENUATE DOSPAN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012546-001	TENUATE DOSPAN	75MG	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N012546-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
0029c986-f448-4e26-865d-441bd9700d12	Product name	1	20201013
a29cb53e-8fe0-4754-9013-e084b50c1c66	Product name	1	20170614
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-691-00	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-01	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-09	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-12	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-18	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-40	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-42	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-45	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-50	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-52	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-54	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-57	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-59	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-60	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-61	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-63	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-66	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-67	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-69	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-71	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-74	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-78	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-79	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-80	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-81	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-82	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-84	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-85	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-90	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-91	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-92	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-93	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-94	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-95	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-96	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-97	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-98	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only
12634-691-99	Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-691-00	diethylpropion hydrochloride er	10 in 1 BOTTLE	TABLET	10	6
12634-691-01	diethylpropion hydrochloride er	100 in 1 BOTTLE	TABLET	100	6
12634-691-09	diethylpropion hydrochloride er	35 in 1 BOTTLE	TABLET	35	6
12634-691-12	diethylpropion hydrochloride er	120 in 1 BOTTLE	TABLET	120	6
12634-691-18	diethylpropion hydrochloride er	180 in 1 BOTTLE	TABLET	180	6
12634-691-40	diethylpropion hydrochloride er	40 in 1 BOTTLE	TABLET	40	6
12634-691-42	diethylpropion hydrochloride er	42 in 1 BOTTLE	TABLET	42	6
12634-691-45	diethylpropion hydrochloride er	45 in 1 BOTTLE	TABLET	45	6
12634-691-50	diethylpropion hydrochloride er	50 in 1 BOTTLE	TABLET	50	6
12634-691-52	diethylpropion hydrochloride er	12 in 1 BLISTER PACK	TABLET	12	6
12634-691-54	diethylpropion hydrochloride er	14 in 1 BLISTER PACK	TABLET	14	6
12634-691-57	diethylpropion hydrochloride er	20 in 1 BLISTER PACK	TABLET	20	6
12634-691-59	diethylpropion hydrochloride er	30 in 1 BLISTER PACK	TABLET	30	6
12634-691-60	diethylpropion hydrochloride er	60 in 1 BOTTLE	TABLET	60	6
12634-691-61	diethylpropion hydrochloride er	10 in 1 BLISTER PACK	TABLET	10	6
12634-691-63	diethylpropion hydrochloride er	3 in 1 BLISTER PACK	TABLET	3	6
12634-691-66	diethylpropion hydrochloride er	6 in 1 BLISTER PACK	TABLET	6	6
12634-691-67	diethylpropion hydrochloride er	7 in 1 BLISTER PACK	TABLET	7	6
12634-691-69	diethylpropion hydrochloride er	9 in 1 BLISTER PACK	TABLET	9	6
12634-691-71	diethylpropion hydrochloride er	30 in 1 BOTTLE	TABLET	30	6
12634-691-74	diethylpropion hydrochloride er	24 in 1 BOTTLE	TABLET	24	6
12634-691-78	diethylpropion hydrochloride er	28 in 1 BOTTLE	TABLET	28	6
12634-691-79	diethylpropion hydrochloride er	25 in 1 BOTTLE	TABLET	25	6
12634-691-80	diethylpropion hydrochloride er	20 in 1 BOTTLE	TABLET	20	6
12634-691-81	diethylpropion hydrochloride er	21 in 1 BOTTLE	TABLET	21	6
12634-691-82	diethylpropion hydrochloride er	12 in 1 BOTTLE	TABLET	12	6
12634-691-84	diethylpropion hydrochloride er	14 in 1 BOTTLE	TABLET	14	6
12634-691-85	diethylpropion hydrochloride er	15 in 1 BOTTLE	TABLET	15	6
12634-691-90	diethylpropion hydrochloride er	90 in 1 BOTTLE	TABLET	90	6
12634-691-91	diethylpropion hydrochloride er	1 in 1 BLISTER PACK	TABLET	1	6
12634-691-92	diethylpropion hydrochloride er	2 in 1 BOTTLE	TABLET	2	6
12634-691-93	diethylpropion hydrochloride er	3 in 1 BOTTLE	TABLET	3	6
12634-691-94	diethylpropion hydrochloride er	4 in 1 BOTTLE	TABLET	4	6
12634-691-95	diethylpropion hydrochloride er	5 in 1 BOTTLE	TABLET	5	6
12634-691-96	diethylpropion hydrochloride er	6 in 1 BOTTLE	TABLET	6	6
12634-691-97	diethylpropion hydrochloride er	7 in 1 BOTTLE	TABLET	7	6
12634-691-98	diethylpropion hydrochloride er	8 in 1 BOTTLE	TABLET	8	6
12634-691-99	diethylpropion hydrochloride er	9 in 1 BOTTLE	TABLET	9	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-691	DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC.]	6	Legacy NDC, 38 package rows	20170125_46d9dd37-a8c4-4c01-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19V2PL39NG	DIETHYLPROPION HYDROCHLORIDE	134-80-5	DIETHYLPROPION HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978668	diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet	PSN	46d9dd37-a8c4-4c01-e054-00144ff8d46c	6
978668	24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet	SCD	46d9dd37-a8c4-4c01-e054-00144ff8d46c	6
978668	diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet	SY	46d9dd37-a8c4-4c01-e054-00144ff8d46c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-691-00	12634069100	10 in 1 BOTTLE	Historical
12634-691-01	12634069101	100 in 1 BOTTLE	Historical
12634-691-09	12634069109	35 in 1 BOTTLE	Historical
12634-691-12	12634069112	120 in 1 BOTTLE	Historical
12634-691-18	12634069118	180 in 1 BOTTLE	Historical
12634-691-40	12634069140	40 in 1 BOTTLE	Historical
12634-691-42	12634069142	42 in 1 BOTTLE	Historical
12634-691-45	12634069145	45 in 1 BOTTLE	Historical
12634-691-50	12634069150	50 in 1 BOTTLE	Historical
12634-691-52	12634069152	12 in 1 BLISTER PACK	Historical
12634-691-54	12634069154	14 in 1 BLISTER PACK	Historical
12634-691-57	12634069157	20 in 1 BLISTER PACK	Historical
12634-691-59	12634069159	30 in 1 BLISTER PACK	Historical
12634-691-60	12634069160	60 in 1 BOTTLE	Historical
12634-691-61	12634069161	10 in 1 BLISTER PACK	Historical
12634-691-63	12634069163	3 in 1 BLISTER PACK	Historical
12634-691-66	12634069166	6 in 1 BLISTER PACK	Historical
12634-691-67	12634069167	7 in 1 BLISTER PACK	Historical
12634-691-69	12634069169	9 in 1 BLISTER PACK	Historical
12634-691-71	12634069171	30 in 1 BOTTLE	Historical
12634-691-74	12634069174	24 in 1 BOTTLE	Historical
12634-691-78	12634069178	28 in 1 BOTTLE	Historical
12634-691-79	12634069179	25 in 1 BOTTLE	Historical
12634-691-80	12634069180	20 in 1 BOTTLE	Historical
12634-691-81	12634069181	21 in 1 BOTTLE	Historical
12634-691-82	12634069182	12 in 1 BOTTLE	Historical
12634-691-84	12634069184	14 in 1 BOTTLE	Historical
12634-691-85	12634069185	15 in 1 BOTTLE	Historical
12634-691-90	12634069190	90 in 1 BOTTLE	Historical
12634-691-91	12634069191	1 in 1 BLISTER PACK	Historical
12634-691-92	12634069192	2 in 1 BOTTLE	Historical
12634-691-93	12634069193	3 in 1 BOTTLE	Historical
12634-691-94	12634069194	4 in 1 BOTTLE	Historical
12634-691-95	12634069195	5 in 1 BOTTLE	Historical
12634-691-96	12634069196	6 in 1 BOTTLE	Historical
12634-691-97	12634069197	7 in 1 BOTTLE	Historical
12634-691-98	12634069198	8 in 1 BOTTLE	Historical
12634-691-99	12634069199	9 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diethylpropion HCl USP C-IV Controlled-Release 75 mg Tablets Rx only	Apotheca Inc.	2017-01-24	HUMAN PRESCRIPTION DRUG LABEL	6