Amphetamine Sulfate

Product NDC: 57664-062
11-digit product format: 576640062
Labeler code: 57664
Product ID: 57664-062_278f897d-b963-43a5-ae16-58267d1aecd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA214574
Marketing category: ANDA
Marketing start: 2021-01-27
Marketing end: 0000-00-00
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: 2023-12-31
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	57664-062		D	Discontinued by firm		2026-08-11
excluded package	package	57664-062	57664-062-88	D	Discontinued by firm		2026-08-11

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
A214574-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET / ORAL			2021-01-27
A214574-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET / ORAL			2021-01-27

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 · 70 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	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL		2021-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL		2021-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214574-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-01-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214574-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-01-27	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214574-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214574-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214574-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214574-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214574-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214574-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214574-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214574-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214574-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214574-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214574-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214574-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214574-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A214574-002	AA	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214574-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214574-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214574-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214574-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214574-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214574-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214574-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214574-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214574-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214574-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214574-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214574-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214574-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214574-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214574-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214574-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214574-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214574-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214574-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214574-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214574-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214574-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214574-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A214574-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214574-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214574-002	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-062-88	EA - Each	57664-062	d17d3ada-a2c5-4447-b250-c6d0747ce956	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-062	AMPHETAMINE SULFATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Legacy NDC	20250522_8fa41f19-0b2b-4b6a-aa5f-d28f8213a6bc.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-062-88	57664006288	100 TABLET in 1 BOTTLE (57664-062-88)	100 tablet	2021-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amphetamine Sulfate Tablets, USP, CII	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc.	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	4