BENZPHETAMINE HYDROCHLORIDE

Product NDC: 76519-1154
11-digit product format: 765191154
Labeler code: 76519
Product ID: 76519-1154_60a394a5-04c7-819e-e053-2a91aa0add1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZPHETAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: H. J. Harkins Company Inc.
Application: ANDA090968
Marketing category: ANDA
Marketing start: 2017-06-07
Marketing end: 0000-00-00
Substance: BENZPHETAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule: CIII
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76519-1154		I	Inactivated by FDA		2026-08-03
excluded package	package	76519-1154	76519-1154-1	I	Inactivated by FDA		2026-08-03

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 1 · 42 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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`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	76519-1154-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76519-1154-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76519-1154-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76519-1154-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76519-1154-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76519-1154-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76519-1154-1	`9bebd1f3094a…`	`5416666fcb17…`

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
A090968-001	BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090968-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090968-001	BENZPHETAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	2010-07-20	`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	A090968-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090968-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090968-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090968-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090968-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090968-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090968-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090968-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090968-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090968-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090968-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090968-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090968-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090968-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090968-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090968-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090968-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090968-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090968-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090968-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090968-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090968-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090968-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090968-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090968-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090968-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090968-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090968-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090968-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090968-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090968-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090968-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090968-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090968-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090968-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090968-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090968-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090968-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090968-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090968-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e1de3598-2dc1-55e2-fc07-ee2e74c73cfc	Product name	3	20201013
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76519-1154-1	2020-01-31	C162847	48780-1	9d75b9cf-eb9a-f424-e053-dadaa90a57ce	60a394a5-04c6-819e-e053-2a91aa0add1f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76519-1154-1	BENZPHETAMINE HYDROCHLORIDE	100 in 1 CONTAINER	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76519-1154	BENZPHETAMINE HYDROCHLORIDE TABLET [H. J. HARKINS COMPANY INC.]	1	Legacy NDC, 1 package rows	20171219_60a394a5-04c6-819e-e053-2a91aa0add1f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	KVK-TECH, INC	14d4589d-7f1c-4b6e-9557-59dad39b0960	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090968 application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b7014af-0cc9-4199-90f2-ec07ac02f8cf	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090968 application number: ANDA090968
BENZPHETAMINE HYDROCHLORIDE	BENZPHETAMINE HYDROCHLORIDE	Bryant Ranch Prepack	1c726aa7-3b78-45de-aca0-fd8a5fff9403	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090968 application number: ANDA090968
benzphetamine hydrochloride	BENZPHETAMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f5c3c2ed-54a2-1def-e053-2995a90ab4e3	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090968 application number: ANDA090968

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
904368	benzphetamine HCl 50 MG Oral Tablet	PSN	60a394a5-04c6-819e-e053-2a91aa0add1f	1
904368	benzphetamine hydrochloride 50 MG Oral Tablet	SCD	60a394a5-04c6-819e-e053-2a91aa0add1f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76519-1154-1	76519115401	100 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZPHETAMINE HYDROCHLORIDE - H. J. Harkins Company Inc.	H. J. Harkins Company Inc.	2017-12-18	HUMAN PRESCRIPTION DRUG LABEL	1