dextroamphetamine sulfate

Product NDC: 45963-304
11-digit product format: 459630304
Labeler code: 45963
Product ID: 45963-304_efcdbc4d-7174-4356-9aa2-d557735e2048
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA203901
Marketing category: ANDA
Marketing start: 2014-06-19
Substance: DEXTROAMPHETAMINE SULFATE
Active strength: 10 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203901-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30
A203901-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30
A203901-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203901-001	AB
A203901-002	AB
A203901-003	AB

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 4 · 123 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	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203901-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203901-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203901-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203901-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203901-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203901-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203901-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203901-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203901-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203901-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203901-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203901-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203901-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203901-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203901-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203901-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: dextroamphetamine sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884520	Internal RxNorm lookup
884532	Internal RxNorm lookup
884535	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
9e92ccc3-d81c-461d-a19f-7e9b582be357	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
45963-304-09	dextroamphetamine sulfate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-304-09	EA - Each	45963-304	16dbf267-f95f-4a4e-8097-429e7e54ca02	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-304	DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	18	Current NDC, Legacy NDC, 1 package rows	20241025_9e92ccc3-d81c-461d-a19f-7e9b582be357.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	Actavis Pharma, Inc.	9e92ccc3-d81c-461d-a19f-7e9b582be357	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203901 application number: ANDA203901 ndc (product): 45963-304

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
884520	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule	PSN	9e92ccc3-d81c-461d-a19f-7e9b582be357	20
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	PSN	9e92ccc3-d81c-461d-a19f-7e9b582be357	20
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	PSN	9e92ccc3-d81c-461d-a19f-7e9b582be357	20
884520	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule	SCD	9e92ccc3-d81c-461d-a19f-7e9b582be357	20
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	SCD	9e92ccc3-d81c-461d-a19f-7e9b582be357	20
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	9e92ccc3-d81c-461d-a19f-7e9b582be357	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45963-304-09	45963030409	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)	2014-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Extended-Release Capsules CII	Actavis Pharma, Inc.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	20