Amphetamine Sulfate

Product NDC: 52536-057
11-digit product format: 525360057
Labeler code: 52536
Product ID: 52536-057_87867bbf-4f82-42a0-9586-a9f530be1d2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Wilshire Pharmaceuticals, Inc.
Application: ANDA200166
Marketing category: ANDA
Marketing start: 2018-03-29
Substance: AMPHETAMINE SULFATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52536-057	52536-057-10	D	Discontinued by firm		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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200166-001	EVEKEO	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2012-08-09
A200166-002	EVEKEO	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	RS	2012-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A200166-001	AA
A200166-002	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 3 · 82 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	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200166-001	EVEKEO	5MG	TABLET / ORAL	AA		2012-08-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200166-002	EVEKEO	10MG	TABLET / ORAL	AA	RS	2012-08-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A200166-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200166-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200166-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200166-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200166-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200166-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200166-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200166-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200166-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200166-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200166-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200166-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200166-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200166-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200166-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200166-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200166-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200166-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200166-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200166-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200166-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200166-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200166-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200166-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200166-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200166-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200166-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200166-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200166-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amphetamine Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPHETAMINE SULFATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6DPV8NK46S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884655	Internal RxNorm lookup
1600695	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
91add2e3-8359-47dc-b79f-197d36b02819	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21	Product name	7	20250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b	Product name	2	20250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6	Product name	3	20231213
4496d022-9224-4ee0-943a-50fbe6cd7123	Product name	2	20220901
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
93730fbf-8b45-4623-b27d-cf03825d04b3	Product name	5	20220314
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52536-057-03	Amphetamine Sulfate	30 in 1 BOTTLE	TABLET	30		6
52536-057-10	Amphetamine Sulfate	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-057-03	EA - Each	52536-057	2b373779-75c4-42dd-b4ce-a1bb6b736999	1	2021-05-05
52536-057-10	EA - Each	52536-057	d9efaff6-6a6c-46a2-b411-3fec1dd40a5d	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52536-057	AMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS]	4	Current NDC, Legacy NDC, 2 package rows	20231118_91add2e3-8359-47dc-b79f-197d36b02819.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	b94e2562-fd19-455f-ac10-2cc24302d27a	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	920f99f4-ab78-4eed-9d80-08a2ebd0b769	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Wilshire Pharmaceuticals, Inc.	91add2e3-8359-47dc-b79f-197d36b02819	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166 ndc (product): 52536-057
Evekeo	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	f469fb38-0380-4621-9db3-a4f429126156	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	674940ec-1714-4e41-b471-2a8c8a6c5ade	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166
Amphetamine Sulfate	AMPHETAMINE SULFATE	Bryant Ranch Prepack	c972a6a4-a96c-4d70-b4c4-eef9e990abb4	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200166 application number: ANDA200166

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	674940ec-1714-4e41-b471-2a8c8a6c5ade	104
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	674940ec-1714-4e41-b471-2a8c8a6c5ade	104
1600695	amphetamine sulfate 10 MG Oral Tablet	PSN	91add2e3-8359-47dc-b79f-197d36b02819	6
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	91add2e3-8359-47dc-b79f-197d36b02819	6
1600695	amphetamine sulfate 10 MG Oral Tablet	SCD	91add2e3-8359-47dc-b79f-197d36b02819	6
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	91add2e3-8359-47dc-b79f-197d36b02819	6
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	920f99f4-ab78-4eed-9d80-08a2ebd0b769	3
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	920f99f4-ab78-4eed-9d80-08a2ebd0b769	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52536-057-03	52536005703	30 TABLET in 1 BOTTLE (52536-057-03)	30 tablet	2021-01-07	0000-00-00	No	No	Current
52536-057-10	52536005710	100 TABLET in 1 BOTTLE (52536-057-10)	100 tablet	2018-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMPHETAMINE SULFATE TABLETS, USP, CII	Bryant Ranch Prepack	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	3
AMPHETAMINE SULFATE TABLETS, USP, CII	Wilshire Pharmaceuticals, Inc.	2025-10-24	Human Prescription Drug Label	6
AMPHETAMINE SULFATE TABLETS, USP, CII	Bryant Ranch Prepack	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL	104