DIETHYLPROPION HYDROCHLORIDE

Product NDC: 68071-3836
11-digit product format: 680713836
Labeler code: 68071
Product ID: 68071-3836_335fb614-bf6d-d489-e063-6294a90ab3e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIETHYLPROPION HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA201212
Marketing category: ANDA
Marketing start: 2010-12-27
Substance: DIETHYLPROPION HYDROCHLORIDE
Active strength: 25 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
A201212-001	DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2010-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201212-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201212-001	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-12-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201212-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201212-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201212-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201212-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201212-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201212-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201212-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201212-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201212-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201212-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201212-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201212-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201212-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201212-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201212-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201212-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201212-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201212-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201212-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201212-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201212-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201212-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201212-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201212-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201212-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201212-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201212-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201212-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201212-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201212-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201212-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201212-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201212-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201212-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201212-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201212-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201212-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201212-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201212-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201212-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: DIETHYLPROPION HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIETHYLPROPION HYDROCHLORIDE	25 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
978654	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
335fb85d-8b1f-e648-e063-6294a90aa158	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
68071-3836-1	DIETHYLPROPION HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3836	DIETHYLPROPION HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Current NDC, 1 package rows	20250424_335fb85d-8b1f-e648-e063-6294a90aa158.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Martek Pharmacal Co.	130511dc-8f01-02ca-e063-6394a90a671b	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	335fb85d-8b1f-e648-e063-6294a90aa158	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212 ndc (product): 68071-3836
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Calvin Scott & Co., Inc.	fa48ad75-4fc8-4355-a19d-cd1b9d87f553	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe7e5022-8b58-aa4f-e053-6294a90af65e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fb8e2f1b-24ef-4e1d-a493-4c3b3de05b26	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	KVK-TECH, INC	3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201212 application number: ANDA201212

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	335fb85d-8b1f-e648-e063-6294a90aa158	1
978654	diethylpropion hydrochloride 25 MG Oral Tablet	SCD	335fb85d-8b1f-e648-e063-6294a90aa158	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3836-1	68071383601	100 TABLET in 1 BOTTLE (68071-3836-1)	100 tablet	2025-04-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diethylpropion HCl USP CIV 25 mg Tablets Rx Only	NuCare Pharmaceuticals,Inc.	2025-04-22	HUMAN PRESCRIPTION DRUG LABEL	1