Dextroamphetamine Sulfate

Product NDC: 52536-500
11-digit product format: 525360500
Labeler code: 52536
Product ID: 52536-500_3777bded-3f46-0856-e063-6394a90a47b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Wilshire Pharmaceuticals, Inc.
Application: ANDA090533
Marketing category: ANDA
Marketing start: 2012-07-16
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

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52536-500	52536-500-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A090533-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25
A090533-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25
A090533-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25
A090533-004	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25
A090533-005	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25
A090533-006	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25
A090533-007	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090533-001	AA
A090533-002	AA
A090533-003	AA
A090533-004	AA
A090533-005	AA
A090533-006	AA
A090533-007	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 8 · 294 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	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-006	DEXTROAMPHETAMINE SULFATE	20MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-007	DEXTROAMPHETAMINE SULFATE	30MG	TABLET / ORAL	AA	2011-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-001	DEXTROAMPHETAMINE SULFATE	2.5MG	TABLET / ORAL	AA	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-002	DEXTROAMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-003	DEXTROAMPHETAMINE SULFATE	7.5MG	TABLET / ORAL	AA	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-004	DEXTROAMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2011-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-005	DEXTROAMPHETAMINE SULFATE	15MG	TABLET / ORAL	AA	2011-10-25	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 209 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090533-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-004	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-005	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-006	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090533-007	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090533-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-004	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-005	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-006	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090533-007	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-004	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-005	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-006	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090533-007	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090533-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-004	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-005	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-006	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090533-007	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-004	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-005	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-006	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090533-007	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-004	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090533-005	AA	1	`b8a1b40f171c…`

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884385	Internal RxNorm lookup
884386	Internal RxNorm lookup
884684	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
6b8c97ac-c83c-4a1f-a33c-121239253abf	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
52536-500-01	Dextroamphetamine Sulfate	100 in 1 BOTTLE	TABLET	100		14
52536-500-03	Dextroamphetamine Sulfate	30 in 1 BOTTLE	TABLET	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-500-01	EA - Each	52536-500	00e76cc8-985c-4725-b82b-37b9a5749387	1	2013-02-13
52536-500-03	EA - Each	52536-500	9d7679a3-62d9-462d-a0b3-5b3676ce3fa3	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextroamphetamine Sulfate	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
Dextroamphetamine	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
crospovidone	INACTIVE INGREDIENT	68401960MK	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
FD&C Yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52536-500	DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240724_6b8c97ac-c83c-4a1f-a33c-121239253abf.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zenzedi	DEXTROAMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	d6394df5-f2c9-47eb-b57e-f3e9cfd94f84	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	9346ff55-b751-4919-ae63-eb58b69e3f0f	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	54b122b0-2ec8-43c9-86e8-a3538a83c776	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da2	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	fc164327-dd48-4851-b613-71d957ee6066	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Bryant Ranch Prepack	b40c9a90-7e2e-48d6-adb6-2351c0ca621d	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Wilshire Pharmaceuticals, Inc.	6b8c97ac-c83c-4a1f-a33c-121239253abf	2025-06-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090533 application number: ANDA090533 ndc (product): 52536-500

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	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884684	dextroamphetamine sulfate 15 MG Oral Tablet	PSN	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
1535454	dextroamphetamine sulfate 20 MG Oral Tablet	PSN	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
1535470	dextroamphetamine sulfate 30 MG Oral Tablet	PSN	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884385	dextroamphetamine sulfate 10 MG Oral Tablet	SCD	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884684	dextroamphetamine sulfate 15 MG Oral Tablet	SCD	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
1535454	dextroamphetamine sulfate 20 MG Oral Tablet	SCD	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
1535470	dextroamphetamine sulfate 30 MG Oral Tablet	SCD	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	6b8c97ac-c83c-4a1f-a33c-121239253abf	14
884386	dextroamphetamine sulfate 5 MG Oral Tablet	PSN	fc164327-dd48-4851-b613-71d957ee6066	3
884386	dextroamphetamine sulfate 5 MG Oral Tablet	SCD	fc164327-dd48-4851-b613-71d957ee6066	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52536-500-01	52536050001	100 TABLET in 1 BOTTLE (52536-500-01)	100 tablet	2012-07-16	0000-00-00	No	No	Current
52536-500-03	52536050003	30 TABLET in 1 BOTTLE (52536-500-03)	30 tablet	2021-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Tablets, USP CII	Bryant Ranch Prepack	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	3
Dextroamphetamine Sulfate Tablets, USP CII	Wilshire Pharmaceuticals, Inc.	2025-06-13	HUMAN PRESCRIPTION DRUG LABEL	14