Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Product NDC: 43975-333
11-digit product format: 439750333
Labeler code: 43975
Product ID: 43975-333_dd10c2a1-9bf7-4603-84a1-c122952c39a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amerigen Pharmaceuticals Inc.
Application: NDA021303
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-12-03
Marketing end: 2023-01-31
Substance: DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
Active strength: 4 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],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	43975-333		D	Discontinued by firm		2026-08-11
excluded package	package	43975-333	43975-333-10	D	Discontinued by firm		2026-08-11

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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`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	43975-333-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021303-001	ADDERALL XR 10	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-002	ADDERALL XR 20	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-003	ADDERALL XR 30	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11
N021303-004	ADDERALL XR 25	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-005	ADDERALL XR 5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-006	ADDERALL XR 15	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021303-001	AB1
N021303-002	AB1
N021303-003	AB1
N021303-004	AB1
N021303-005	AB1
N021303-006	AB1

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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N021303-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	AB1	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43975-333-10	EA - Each	43975-333	dd767325-5363-48fa-80a3-9cc8dbcf8b85	1	2018-12-13

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adderall XR	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE	Takeda Pharmaceuticals America, Inc.	aff45863-ffe1-4d4f-8acf-c7081512a6c0	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Sandoz Inc	6f637e8d-7c2e-47fa-a43c-3250c51aed77	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Prasco Laboratories	f85af6ee-9029-42de-adea-6dbb8642952c	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE
G83415V073	DEXTROAMPHETAMINE SACCHARATE	350708-40-6	DEXTROAMPHETAMINE SACCHARATE
O1ZPV620O4	AMPHETAMINE ASPARTATE MONOHYDRATE	851591-76-9	AMPHETAMINE ASPARTATE MONOHYDRATE
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43975-333-10	43975033310	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-333-10)	2018-12-03	2023-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SULFATE	Amerigen Pharmaceuticals Inc.	2019-12-06	HUMAN PRESCRIPTION DRUG LABEL	2