dextroamphetamine sulfate

Product NDC: 45963-304
11-digit product format: 459630304
Labeler code: 45963
Product ID: 45963-304_fd3ab328-e56c-4180-a0df-d6aa0375cf58
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 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203901-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203901-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203901-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2012-11-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A203901-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203901-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203901-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203901-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203901-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203901-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203901-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203901-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203901-003	AB	1	`caaa826d4ba7…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	10 mg/1

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

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	21