Diethylpropion Hydrochloride

Product NDC: 81665-109
11-digit product format: 816650109
Labeler code: 81665
Product ID: 81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diethylpropion Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: OMNIVIUM PHARMACEUTICALS LLC.
Application: ANDA091680
Marketing category: ANDA
Marketing start: 2025-09-19
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: 2026-12-31
Current FDA listing: Yes

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
A091680-001	DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091680-001	DIETHYLPROPION HYDROCHLORIDE	75MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2011-10-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091680-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091680-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091680-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091680-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091680-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091680-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091680-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091680-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091680-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091680-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091680-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091680-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091680-001	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A091680-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091680-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091680-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091680-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091680-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diethylpropion Hydrochloride
Brand name suffix: ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIETHYLPROPION HYDROCHLORIDE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19V2PL39NG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978668	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
cd4f2b19-8752-4fed-81f3-d3074ade613c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81665-109-10	Diethylpropion HydrochlorideER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1
81665-109-25	Diethylpropion HydrochlorideER	250 in 1 BOTTLE	TABLET, EXTENDED RELEASE	250		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81665-109-10	EA - Each	81665-109	966389f0-a0d7-4477-8b73-a4ba6ded4f7b	1	2025-12-16

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
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	A-S Medication Solutions	04f1a804-00f1-48f5-acfa-0ed1a8544784	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0d213a24-ebbf-41df-8f32-de44a572829e	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	OMNIVIUM PHARMACEUTICALS LLC.	cd4f2b19-8752-4fed-81f3-d3074ade613c	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680 ndc (product): 81665-109
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	335265e0-1d5d-31fb-e063-6394a90a2e75	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Calvin Scott & Co., Inc.	d6cde8cc-26ae-4087-8eac-b11192749cc5	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
DIETHYLPROPION HYDROCHLORIDE ER	DIETHYLPROPION HYDROCHLORIDE ER	Directrx	d44e23db-381a-cfc3-e053-2995a90a13c8	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	89306917-a65b-40d4-9c51-d59ac0ad2017	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Lannett Company, Inc.	dab53f4f-68d4-4477-a2b6-ad44a956332b	2022-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Proficient Rx LP	15110f70-6602-4e05-a4b5-716a86dcaed5	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091680 application number: ANDA091680

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	cd4f2b19-8752-4fed-81f3-d3074ade613c	1
978668	24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet	SCD	cd4f2b19-8752-4fed-81f3-d3074ade613c	1
978668	diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet	SY	cd4f2b19-8752-4fed-81f3-d3074ade613c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81665-109-10	81665010910	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10)	2025-09-19	No	No	Current
81665-109-25	81665010925	250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25)	2025-09-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only	OMNIVIUM PHARMACEUTICALS LLC.	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	1