DEXTROAMPHETAMINE SULFATE

Product NDC: 68382-941
11-digit product format: 683820941
Labeler code: 68382
Product ID: 68382-941_282d4715-9c0f-484a-a6b3-aac87feb347c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROAMPHETAMINE SULFATE
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA206588
Marketing category: ANDA
Marketing start: 2016-03-28
Marketing end: 0000-00-00
Substance: DEXTROAMPHETAMINE 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: 2022-12-31
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	68382-941		I	Inactivated by FDA		2026-08-17
excluded package	package	68382-941	68382-941-01	I	Inactivated by FDA		2026-08-17

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 · 32 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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`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	68382-941-01	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206588-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL			2016-03-28
A206588-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL			2016-03-28

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 · 84 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
2026-08-18 06:07:40	2026-07	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2016-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2016-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2016-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2016-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2016-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2016-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206588-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2016-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206588-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2016-03-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A206588-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206588-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206588-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206588-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206588-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206588-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206588-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206588-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206588-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206588-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206588-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206588-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206588-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206588-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206588-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206588-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206588-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206588-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206588-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206588-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206588-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206588-002	AA	1	`ea99ee380514…`

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
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	5	20230426
8170729e-5ba4-46f9-830f-5f0fae5942ce	Product name	1	20230103
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-941-01	2022-07-29	C162847	48780-1	e4f33bdf-b1da-d8a0-e053-dadaa90a6e4e	DEXTROAMPHETAMINE SULFATE - dextroamphetamine sulfate tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-941-01	DEXTROAMPHETAMINE SULFATE	100 in 1 BOTTLE	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-941-01	EA - Each	68382-941	86f079ec-1d31-4262-8b10-e49aa8d0993a	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-941	DEXTROAMPHETAMINE SULFATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ]	7	Legacy NDC, 1 package rows	20211218_0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884385	dextroamphetamine sulfate 10 MG Oral Tablet	PSN	0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e	7
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e	7
884385	dextroamphetamine sulfate 10 MG Oral Tablet	SCD	0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e	7
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-941-01	68382094101	100 TABLET in 1 BOTTLE (68382-941-01)	100 tablet	2016-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SULFATE - dextroamphetamine sulfate tablet	Zydus Pharmaceuticals (USA) Inc. \| Nesher Pharmaceuticals (USA) LLC	2021-12-17	HUMAN PRESCRIPTION DRUG LABEL	7