Dextroamphetamine Sulfate

Product NDC: 0406-8962
11-digit product format: 004068962
Labeler code: 0406
Product ID: 0406-8962_78bafc02-003f-497f-b8c0-2bb063b3fa35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA076353
Marketing category: ANDA
Marketing start: 2003-05-06
Substance: DEXTROAMPHETAMINE SULFATE
Active strength: 15 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076353-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06
A076353-002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06
A076353-003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076353-001	AB
A076353-002	AB
A076353-003	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	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-002	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-003	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076353-001	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2003-05-06	`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	A076353-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076353-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076353-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076353-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076353-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076353-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076353-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076353-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076353-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076353-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076353-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076353-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076353-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076353-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076353-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076353-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076353-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076353-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076353-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076353-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dextroamphetamine Sulfate
Brand name suffix: Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	15 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
69c40af8-3710-46bf-bd3d-137fe5eea23e	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
0406-8962-01	Dextroamphetamine SulfateExtended-Release	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-8962-01	EA - Each	0406-8962	2460cb24-4c96-4462-9139-5a9f9e2adfa9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED	INACTIVE INGREDIENT	QG4MW19XYX	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
ETHYLCELLULOSE (20 MPA.S)	INACTIVE INGREDIENT	BJG0S321QY	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
HYPROMELLOSE 2208 (100000 MPA.S)	INACTIVE INGREDIENT	VM7F0B23ZI	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [MALLINCKRODT, INC.]	11
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-8962	DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC]	22	Current NDC, Legacy NDC, 1 package rows	20240719_69c40af8-3710-46bf-bd3d-137fe5eea23e.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 Extended-Release	DEXTROAMPHETAMINE SULFATE	SpecGx LLC	69c40af8-3710-46bf-bd3d-137fe5eea23e	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076353 application number: ANDA076353 ndc (product): 0406-8962

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	69c40af8-3710-46bf-bd3d-137fe5eea23e	23
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	PSN	69c40af8-3710-46bf-bd3d-137fe5eea23e	23
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	PSN	69c40af8-3710-46bf-bd3d-137fe5eea23e	23
884520	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule	SCD	69c40af8-3710-46bf-bd3d-137fe5eea23e	23
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	SCD	69c40af8-3710-46bf-bd3d-137fe5eea23e	23
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	69c40af8-3710-46bf-bd3d-137fe5eea23e	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-8962-01	00406896201	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8962-01)	2003-05-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Extended-Release Capsules, CII Rx only	SpecGx LLC	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	23
Dextroamphetamine Sulfate Extended-Release Capsules CII Rx Only 8415021/0718OS	American Health Packaging	2019-04-12	HUMAN PRESCRIPTION DRUG LABEL	6