DEXTROAMPHETAMINE SULFATE

Product NDC: 11534-188
11-digit product format: 115340188
Labeler code: 11534
Product ID: 11534-188_2c5c3b56-a600-4196-9e40-ae80e4586527
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: SUNRISE PHARMACEUTICAL, INC.
Application: ANDA210059
Marketing category: ANDA
Marketing start: 2018-07-04
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: 2026-12-31
Current FDA listing: Yes

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
A210059-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2017-10-18
A210059-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2017-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210059-001	AA
A210059-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210059-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2017-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210059-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2017-10-18	`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	A210059-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210059-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210059-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210059-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210059-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210059-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210059-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210059-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210059-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210059-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210059-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210059-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210059-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210059-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210059-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210059-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210059-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210059-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210059-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210059-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210059-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210059-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210059-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210059-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210059-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210059-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210059-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210059-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210059-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: DEXTROAMPHETAMINE SULFATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE 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
JJ768O327N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884385	Internal RxNorm lookup
884386	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
93b3a40f-b7ac-4047-8ff5-3e34c2d75193	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11534-188-01	DEXTROAMPHETAMINE SULFATE	100 in 1 BOTTLE	TABLET	100		11
11534-188-03	DEXTROAMPHETAMINE SULFATE	1000 in 1 BOTTLE	TABLET	1000		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11534-188-01	EA - Each	11534-188	ad0fcc13-334c-43ff-bd8c-3d3e116f4517	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-188	DEXTROAMPHETAMINE SULFATE TABLET [SUNRISE PHARMACEUTICAL, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20241205_93b3a40f-b7ac-4047-8ff5-3e34c2d75193.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	466cbae8-4f67-4a65-b670-ada6a953d550	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	0ef920a9-c5b9-4d31-a478-ee18d22a3c5b	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	SUNRISE PHARMACEUTICAL, INC.	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059 ndc (product): 11534-188
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	c706a849-9df6-43ca-9ac6-1d9ce6b8e855	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059
DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	5c493bef-0c3e-49f5-b55a-f1446094f5da	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210059 application number: ANDA210059

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
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	466cbae8-4f67-4a65-b670-ada6a953d550	106
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	466cbae8-4f67-4a65-b670-ada6a953d550	106
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	5c493bef-0c3e-49f5-b55a-f1446094f5da	103
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	5c493bef-0c3e-49f5-b55a-f1446094f5da	103
884385	dextroamphetamine sulfate 10 MG Oral Tablet	PSN	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	11
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	11
884385	dextroamphetamine sulfate 10 MG Oral Tablet	SCD	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	11
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	93b3a40f-b7ac-4047-8ff5-3e34c2d75193	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11534-188-01	11534018801	100 TABLET in 1 BOTTLE (11534-188-01)	100 tablet	2018-07-04	0000-00-00	No	No	Current
11534-188-03	11534018803	1000 TABLET in 1 BOTTLE (11534-188-03)	1000 tablet	2018-07-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Tablets, USP CII Rx only	Bryant Ranch Prepack	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	106
Dextroamphetamine Sulfate Tablets, USP CII Rx only	SUNRISE PHARMACEUTICAL, INC. \| SUNRISE PHARMACEUTICAL INC.	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	11
Dextroamphetamine Sulfate Tablets, USP CII Rx only	Bryant Ranch Prepack	2024-09-06	HUMAN PRESCRIPTION DRUG LABEL	103