Diethylpropion HCl Controlled-Release

Product NDC: 68387-696
11-digit product format: 683870696
Labeler code: 68387
Product ID: 68387-696_0a14fdc5-2428-46bf-b6d0-88bac7f9158e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diethylpropion hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA011722
Marketing category: ANDA
Marketing start: 2010-06-07
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: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68387-696		I	Inactivated by FDA	2026-08-11
excluded package	package	68387-696	68387-696-07	I	Inactivated by FDA	2026-08-11
excluded package	package	68387-696	68387-696-14	I	Inactivated by FDA	2026-08-11
excluded package	package	68387-696	68387-696-21	I	Inactivated by FDA	2026-08-11
excluded package	package	68387-696	68387-696-28	I	Inactivated by FDA	2026-08-11

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 2 · 110 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	68387-696-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-696-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-696-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-696-07	`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	68387-696-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-696-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-696-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-696-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-696-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-696-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-696-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-696-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-696-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-696-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-696-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-696-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-696-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-696-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-696-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-696-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-696-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-696-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-696-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-696-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-696-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-696-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-696-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-696-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-696-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-696-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-696-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-696-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-696-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-696-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-696-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-696-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-696-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-696-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-696-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-696-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-696-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-696-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-696-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-696-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-696-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-696-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-696-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-696-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68387-696-07	Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets
68387-696-14	Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets
68387-696-21	Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets
68387-696-28	Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68387-696-07	Diethylpropion HCl Controlled-Release	7 in 1 BOTTLE, PLASTIC	TABLET	7	1
68387-696-14	Diethylpropion HCl Controlled-Release	14 in 1 BOTTLE, PLASTIC	TABLET	14	1
68387-696-21	Diethylpropion HCl Controlled-Release	21 in 1 BOTTLE, PLASTIC	TABLET	21	1
68387-696-28	Diethylpropion HCl Controlled-Release	28 in 1 BOTTLE, PLASTIC	TABLET	28	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIETHYLPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	19V2PL39NG	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
DIETHYLPROPION	ACTIVE MOIETY	Q94YYU22B8	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-696	DIETHYLPROPION HCL IMMEDIATE-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET DIETHYLPROPION HCL CONTROLLED-RELEASE (DIETHYLPROPION HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1	Legacy NDC, 4 package rows	20100623_04bd05c4-0d36-4580-94ec-2119d8d58644.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
978654	diethylpropion HCl 25 MG Oral Tablet	PSN	04bd05c4-0d36-4580-94ec-2119d8d58644	1
978668	diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet	PSN	04bd05c4-0d36-4580-94ec-2119d8d58644	1
978668	24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet	SCD	04bd05c4-0d36-4580-94ec-2119d8d58644	1
978654	diethylpropion hydrochloride 25 MG Oral Tablet	SCD	04bd05c4-0d36-4580-94ec-2119d8d58644	1
978668	diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet	SY	04bd05c4-0d36-4580-94ec-2119d8d58644	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-696-07	68387069607	7 in 1 BOTTLE, PLASTIC	Historical
68387-696-14	68387069614	14 in 1 BOTTLE, PLASTIC	Historical
68387-696-21	68387069621	21 in 1 BOTTLE, PLASTIC	Historical
68387-696-28	68387069628	28 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-06-14	HUMAN PRESCRIPTION DRUG LABEL	1