DEXEDRINE

Product NDC: 52054-512
11-digit product format: 520540512
Labeler code: 52054
Product ID: 52054-512_6e6c242b-da63-4bd3-86a6-f22e10419291
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amedra Pharmaceuticals LLC
Application: NDA017078
Marketing category: NDA
Marketing start: 1976-08-02
Marketing end: 2019-12-01
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52054-512		D	Discontinued by firm		2026-08-17
excluded package	package	52054-512	52054-512-09	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52054-512-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52054-512-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52054-512-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52054-512-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52054-512-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52054-512-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52054-512-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52054-512-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52054-512-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52054-512-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52054-512-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52054-512-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	RLD / RS
N017078-001	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-002	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-003	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017078-001	AB
N017078-002	AB
N017078-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N017078-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017078-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017078-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52054-512-09	EA - Each	52054-512	a6341893-4acc-499a-bf6d-c73bd7fa941f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMEDRA PHARMACEUTICALS LLC]	11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals LLC	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017078 application number: NDA017078
Dextroamphetamine Sulfate Extended-Release	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals of New York LLC	2ec5c30f-4eb8-48a5-83c4-236450413464	2023-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017078 application number: NDA017078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXEDRINE ® (dextroamphetamine sulfate) SPANSULE ® sustained release capsules CII Rx Only	Amedra Pharmaceuticals LLC	2018-12-07	HUMAN PRESCRIPTION DRUG LABEL	21