Dextroamphetamine Sulfate

Product NDC: 27808-089
11-digit product format: 278080089
Labeler code: 27808
Product ID: 27808-089_97577638-7333-40a8-87d8-f426b7ee7672
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA206095
Marketing category: ANDA
Marketing start: 2022-08-20
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 43.

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
A206095-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL			2022-08-18
A206095-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL			2022-08-18

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 · 58 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
2026-09-14 22:38:34	2026-08	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL		2022-08-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL		2022-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2022-08-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2022-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206095-001	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2022-08-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206095-002	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2022-08-18	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A206095-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206095-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206095-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206095-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206095-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206095-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206095-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206095-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206095-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206095-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206095-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206095-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206095-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206095-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206095-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206095-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206095-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A206095-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206095-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206095-002	AA	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
9acdf000-fefe-47c7-a44c-0f7a65c5c05c	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
27808-089-01	Dextroamphetamine Sulfate	100 in 1 BOTTLE, PLASTIC	TABLET	100		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-089	DEXTROAMPHETAMINE SULFATE TABLET [TRIS PHARMA INC]	15	Current NDC, Legacy NDC, 1 package rows	20231024_9acdf000-fefe-47c7-a44c-0f7a65c5c05c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Cranbury Pharmaceuticals, LLC	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206095 application number: ANDA206095 ndc (product): 27808-089

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	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	16
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	16
884385	dextroamphetamine sulfate 10 MG Oral Tablet	SCD	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	16
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	9acdf000-fefe-47c7-a44c-0f7a65c5c05c	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
27808-089-01	27808008901	100 TABLET in 1 BOTTLE, PLASTIC (27808-089-01)	100 tablet	2023-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Tablets, USP CII Rx only	Cranbury Pharmaceuticals, LLC \| Tris Pharma Inc	2025-05-19	HUMAN PRESCRIPTION DRUG LABEL	16