Benzphetamine Hydrochloride

Product NDC: 75834-100
11-digit product format: 758340100
Labeler code: 75834
Product ID: 75834-100_103b4cf1-4b5d-44b3-89e2-a393ef4f2276
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzphetamine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA040747
Marketing category: ANDA
Marketing start: 2016-01-15
Marketing end: 0000-00-00
Substance: BENZPHETAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75834-100		D	Discontinued by firm	2026-10-05
excluded package	package	75834-100	75834-100-01	D	Discontinued by firm	2026-10-05
excluded package	package	75834-100	75834-100-05	D	Discontinued by firm	2026-10-05
excluded package	package	75834-100	75834-100-30	D	Discontinued by firm	2026-10-05

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 · 88 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	75834-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75834-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75834-100-30	`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	75834-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75834-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75834-100-30	`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	75834-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75834-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75834-100-30	`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	75834-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75834-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75834-100-30	`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	75834-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75834-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75834-100-30	`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	75834-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75834-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75834-100-30	`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	75834-100-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-100-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75834-100-30	`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	75834-100-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-100-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75834-100-30	`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	75834-100-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-100-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75834-100-30	`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	75834-100-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75834-100-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75834-100-30	`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	75834-100-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75834-100-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75834-100-30	`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	75834-100-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75834-100-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75834-100-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75834-100-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75834-100-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75834-100-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75834-100-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75834-100-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75834-100-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75834-100-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75834-100-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75834-100-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040747-001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL			2007-03-30
A040747-002	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL			2015-11-20

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040747-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	2007-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040747-002	BENZPHETAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	2015-11-20	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e1de3598-2dc1-55e2-fc07-ee2e74c73cfc	Product name	3	20201013

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75834-100-01	2020-01-31	C162847	48780-1	9d75b9d0-d816-f424-e053-dadaa90a57ce	Benzphetamine Hydrochloride Tablets, 25 mg and 50 mg CIII
75834-100-05	2020-01-31	C162847	48780-1	9d75b9d0-d816-f424-e053-dadaa90a57ce	Benzphetamine Hydrochloride Tablets, 25 mg and 50 mg CIII
75834-100-30	2020-01-31	C162847	48780-1	9d75b9d0-d816-f424-e053-dadaa90a57ce	Benzphetamine Hydrochloride Tablets, 25 mg and 50 mg CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-100-01	Benzphetamine Hydrochloride	100 in 1 BOTTLE	TABLET	100	1
75834-100-05	Benzphetamine Hydrochloride	500 in 1 BOTTLE	TABLET	500	1
75834-100-30	Benzphetamine Hydrochloride	30 in 1 BOTTLE	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-100-01	EA - Each	75834-100	0fbbb140-b82e-4451-ae9b-cb80c4a837d0	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-100	BENZPHETAMINE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20160127_5f5b95b3-a18f-4289-b9a6-a3278ef5966d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43DWT87QT7	BENZPHETAMINE HYDROCHLORIDE	5411-22-3	BENZPHETAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904372	benzphetamine HCl 25 MG Oral Tablet	PSN	5f5b95b3-a18f-4289-b9a6-a3278ef5966d	1
904368	benzphetamine HCl 50 MG Oral Tablet	PSN	5f5b95b3-a18f-4289-b9a6-a3278ef5966d	1
904372	benzphetamine hydrochloride 25 MG Oral Tablet	SCD	5f5b95b3-a18f-4289-b9a6-a3278ef5966d	1
904368	benzphetamine hydrochloride 50 MG Oral Tablet	SCD	5f5b95b3-a18f-4289-b9a6-a3278ef5966d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
75834-100-01	75834010001	100 in 1 BOTTLE	Historical
75834-100-05	75834010005	500 in 1 BOTTLE	Historical
75834-100-30	75834010030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzphetamine Hydrochloride Tablets, 25 mg and 50 mg CIII	Nivagen Pharmaceuticals, Inc.	2016-01-25	HUMAN PRESCRIPTION DRUG LABEL	1