Dextroamphetamine Sulfate

Product NDC: 75826-125
Requested package NDC: 75826-125-10
11-digit product format: 758260125
Labeler code: 75826
Product ID: 75826-125_37ddfa9e-e495-a25f-e063-6394a90ac3d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Winder Laboratories LLC
Application: ANDA212160
Marketing category: ANDA
Marketing start: 2021-12-06
Substance: DEXTROAMPHETAMINE SULFATE
Active strength: 20 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212160-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07
A212160-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07
A212160-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07
A212160-004	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07
A212160-005	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07
A212160-006	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07
A212160-007	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A212160-001	AA
A212160-002	AA
A212160-003	AA
A212160-004	AA
A212160-005	AA
A212160-006	AA
A212160-007	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 6 · 231 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	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2021-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2021-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2021-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2021-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2021-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2021-06-07	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A212160-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-004	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-005	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-006	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212160-007	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-004	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-005	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-006	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212160-007	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212160-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-004	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-005	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-006	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212160-007	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-004	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-005	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-006	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212160-007	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-004	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-005	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-006	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212160-007	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-004	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212160-005	AA	1	`03ed91905a0d…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Winder Laboratories LLC	ca1a8890-0675-4c9c-9716-6c28f975d827	2025-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212160 application number: ANDA212160 ndc (package): 75826-125-10 ndc (product): 75826-125 ndc11 (package): 75826012510

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	20 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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884385	Internal RxNorm lookup
884386	Internal RxNorm lookup
884684	Internal RxNorm lookup
1425847	Internal RxNorm lookup
1425854	Internal RxNorm lookup
1535454	Internal RxNorm lookup
1535470	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
ca1a8890-0675-4c9c-9716-6c28f975d827	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
75826-125-10	Dextroamphetamine Sulfate	100 in 1 BOTTLE, PLASTIC	TABLET	100		11
75826-125-30	Dextroamphetamine Sulfate	30 in 1 BOTTLE, PLASTIC	TABLET	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75826-125-10	EA - Each	75826-125	f31ebfaa-c24d-4a4f-a4f6-cddfcecb0547	1	2024-01-04
75826-125-30	EA - Each	75826-125	2105389b-fa6e-4cd5-bd40-60447d5d271f	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75826-125	DEXTROAMPHETAMINE SULFATE TABLET [WINDER LABORATORIES LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240814_ca1a8890-0675-4c9c-9716-6c28f975d827.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	ca1a8890-0675-4c9c-9716-6c28f975d827	11
884684	dextroamphetamine sulfate 15 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1425847	dextroamphetamine sulfate 2.5 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1535454	dextroamphetamine sulfate 20 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1535470	dextroamphetamine sulfate 30 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1425854	dextroamphetamine sulfate 7.5 MG Oral Tablet	PSN	ca1a8890-0675-4c9c-9716-6c28f975d827	11
884385	dextroamphetamine sulfate 10 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
884684	dextroamphetamine sulfate 15 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1425847	dextroamphetamine sulfate 2.5 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1535454	dextroamphetamine sulfate 20 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1535470	dextroamphetamine sulfate 30 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11
1425854	dextroamphetamine sulfate 7.5 MG Oral Tablet	SCD	ca1a8890-0675-4c9c-9716-6c28f975d827	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75826-125-10	75826012510	100 TABLET in 1 BOTTLE, PLASTIC (75826-125-10)	100 tablet	2023-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SULFATE TABLETS USP, CII	Winder Laboratories LLC	2025-06-18	HUMAN PRESCRIPTION DRUG LABEL	11